<![CDATA[The Steely Group: jobboards]]> http://JOBS.THESTEELYGROUP.COM/ en-us <![CDATA[Sr. Manager - Director, Consultant, Regulatory Labeling and Ad Promo]]> Responsibilities:
  • Facilitate and Lead the development, review, approval, and maintenance of the US Package Insert (PI) and Summary of Product Characteristics (SmPC) components for assigned products either globally as a Global Labeling Lead or regional/local as a Regional Labeling Lead
  • Serve as an internal expert on FDA regulations, guidance and enforcement trends governing prescription drug promotion
  • Assess promotional materials to evaluate their completeness, accuracy and compliance with the Office of Prescription Drug Promotion (OPDP) requirements
  • Establish and maintain interactions with FDA regarding promotional materials review and approval
  • Act as a Subject Matter Expert (SME) on local, regional and multi-country regulatory labeling requirements and participate in the sharing of intelligence.
  • Follows Global Labeling procedures and maintains document management systems for assigned products.
  • May develop and implement policies and operational targets
  • May have responsibility for management of employees that may be added to the department.
  • Technical expert with sufficient expertise and experience to be considered for sensitive and/or complex assignments
  • Authors and maintains core labeling documents including Core Data Sheet (CDS), core Patient Information Leaflet (cPIL), core Instructions for Use (cIFU), development Core Data Sheet (dCDS), development Core Instructions for Use (dIFU), and United States Prescribing Information (USPI).
  • Manages compounds with a high degree of complexity from a labeling perspective.
  • Chairs/leads Labeling Working Group and presentations to Cross-Functional Executive Labeling Board meetings.
  • Advises internal and/or external experts on the creation of high quality documents supporting changes to the core labeling documents and manages the annotations within those documents.
  • Provides strategic labeling advice for major regions and works with cross functional teams to ensure that the execution of global regulatory labeling plans are aligned with global regulatory strategies.
  • Provides input and strategic guidance to the Target Product Label.
  • Reviews and provides feedback and approves deviations from core labeling.
  • Ensures deviations from labeling procedures and policies are escalated appropriately.
  • Assists in preparation of responses to labeling-related Health Authority queries.
  • Manages the review and approval of core Dear Health Care Provider (DHCP) letters.


Qualifications:
  • Minimum MS degree or higher in life science.
  • 7+ years of regulatory labeling and Ad Promo experience within the pharmaceutical and biotech industries.
  • Experience in US and global regulatory labeling and Ad Promo environments is preferred.
  • Demonstrate a solid working knowledge of drug development process, as well as FDA and EU labeling
  • Competent knowledge of and demonstrated ability to apply regulatory guidelines pertaining to product labeling and ICH guidelines.
  • Demonstrate strong project management, people management, problem solving, strategic thinking, negotiation, interpersonal and communication skills (both written and oral) attention to detail and ability to work under tight timelines.
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Sun, 24 Jun 2018 00:00:00 EDT 0
<![CDATA[Sr. Manager,/Manager/Associate Manager, Regulatory Operations]]> The successful candidate will be responsible for the maintenance and support of Regulatory systems used to facilitate the creation of compliant submissions and for the maintenance of Regulatory information. They will also support the compilation, archiving, and tracking of regulatory submissions and correspondence interfacing with Regulatory technology and publishing partners.

Job  Responsibilities:
  • Maintain and support Regulatory systems such as electronic document management (EDMS), Regulatory Information Management (RIM), and eCTD publishing
  • Manage and oversee the development of training materials specific to Regulatory systems
  • Liaise with internal and external stakeholders to ensure the compliance of deliverables being transmitted to a health authority
  • Represent Regulatory Operations on internal teams to support filing activities
  • Prepare and transmit electronic submissions (paper submissions, when applicable)
  • Interface with external publishing partners on submission compilation


Qualifications/ Requirements: 
  • 5-7 years’ experience working in a Regulatory Operations environment
  • Detailed knowledge of eCTD publishing systems, EDMS technology, and publishing software
  • Experience managing EDMS, regulatory publishing systems, and tracking databases
  • Detailed knowledge of clinical and nonclinical data standards (ADaM, SDTM, SEND)
  • Expert knowledge of Microsoft Office and Adobe Suite (MS Project is a plus)
  • Demonstrated experience and a clear understanding of submission content and format requirements
  • The ability to multitask, prioritize, and work under pressure in adhering to deadlines
  • Solid experience administering and maintaining Regulatory document authoring templates
  • Strong oral and written communication and interpersonal skills
  • Strong project management and organizational skills
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Thu, 21 Jun 2018 00:00:00 EDT 0
<![CDATA[Sr. Clinical Trial Associate]]>
Primary Responsibilities:
  • Ensure compliance with protocol and overall objectives across all investigator sites
  • Perform project/study management-related responsibilities from inception through database lock by coordinating and tracking activities for protocol and SOP compliance as well as regulatory guidelines
  • Work closely with all functional areas as well as external providers to ensure consistent, high-quality study outcomes
  • Execute study activities according to study protocol, regulatory guidelines and operational plan
  • Review Investigational Drug Brochure (IDB), protocols, Case Report Forms (CRFs) and Informed Consent Forms (ICFs) for a thorough understanding of study drug and procedures
  • Keep abreast of SOPs, Good Clinical Practice (GCP) and ICH guidelines as well as state and federal laws and ethical standards
  • Participate in study start-up, conduct and closeout activities
  • Assist preparation of vendor requests for proposals and track receipt of proposals, MSAs and SOWs
  • Collect and review site regulatory documents for accuracy and completion (i.e. 1572, Financial Disclosure documents, CLIA waivers, etc.)
  • Assemble and distribute regulatory binders to clinical sites
  • Draft and/or assist with preparation of trial-related documents, tools and templates (start-up forms, screening scripts, source documents, study logs)
  • Support project management activities including taking meeting minutes, providing agendas to the clinical team, tracking screening/enrollment across all sites and maintaining study-status trackers.
  • Assist with preparation and distribution of investigator site contracts and budgets
  • Maintain the Trial Master File for all clinical projects


Skills & Requirements:
  • Bachelor’ s Degree in health sciences related field, RN, or related discipline required
  • Minimum 3-5 years relevant experience
  • Excellent written and verbal communication skills
  • Strong PC skills (MS Word, MS Excel, MS Project)
  • Sound analytical and problem-solving skills
  • Act with consistent sense of urgency with acute attention to detail.
  • Working knowledge and experience with Electronic Data Capture (EDC) systems and CTMS preferred.
  • Exceptional organizational and time management skills

 
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Thu, 21 Jun 2018 00:00:00 EDT 0
<![CDATA[Clinical Trial Associate Manager ]]> The Clinical Trial Associate Manager is a line management position. This role will be filled by a CTA who is a highly-skilled specialist contributing to the development of relevant concepts, techniques and processes by assisting and providing oversight to CTA activities and input and guidance to study teams across all ongoing clinical studies. The CTAM may be integrated into a study team based on program needs. Based on experience, the CTAM assumes responsibility for more complex tasks and applies creative and effective solutions where needed. Typically working on assignments requiring judgement and initiatives with an understanding of the implications of the work being performed, the CTAM independently identifies tasks/issues that need to be addressed while being highly organized with the ability to multitask and adjust direction based on changing project/corporate priorities. The CTAM is responsible for providing guidance, mentorship, and training for more junior team members. The CTAM will conduct regular performance reviews with direct reports and will make recommendations regarding resourcing and career progression to Management.

Primary Responsibilities:
  • Ensure compliance with protocol and overall objectives across all investigator sites and studies
  • Ensures project/study management-related responsibilities from inception through database lock by coordinating and tracking activities for protocol and SOP compliance as well as regulatory guidelines are developed and maintained
  • Work closely with all functional areas as well as external providers to ensure consistent, high-quality study outcomes
  • Ensures execution of study activities according to study protocol, regulatory guidelines and operational plan
  • Reviews Investigational Drug Brochure (IDB), protocols, Case Report Forms (CRFs) and Informed Consent Forms (ICFs) for a thorough understanding of study drug and procedures
  • Keeps abreast of SOPs, Good Clinical Practice (GCP) and ICH guidelines as well as state and federal laws and ethical standards
  • Participates in the planning and execution of study start-up, conduct and closeout activities
  • Assist preparation of vendor requests for proposals and track receipt of proposals, MSAs and SOWs
  • Provides oversight for the collection and review of site regulatory documents for accuracy and completion (i.e. 1572, Financial Disclosure documents, CLIA waivers, etc.)
  • Provides oversight for the assembly and distribution of regulatory binders to clinical sites
  • Provides oversight for the development of trial-related documents, tools and templates (start-up forms, screening scripts, source documents, study logs)
  • Provides oversight for project management activities ensuring consistency and completion of tasks such as taking meeting minutes, providing agendas to the clinical team, tracking screening/enrollment across all sites and maintaining study-status trackers
  • Assist with preparation and distribution of investigator site contracts and budgets
  • Provides oversight for the maintenance of the Trial Master File for all clinical projects


Skills & Requirements:
  • Bachelor’ s Degree in health sciences related field, RN, or related discipline required
  • Minimum 3-5 years relevant experience
  • Excellent written and verbal communication skills
  • Strong PC skills (MS Word, MS Excel, MS Project)
  • Sound analytical and problem-solving skills
  • Act with consistent sense of urgency with acute attention to detail
  • Working knowledge and experience with Electronic Data Capture (EDC) systems and CTMS preferred
  • Exceptional organizational and time management skills
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Thu, 21 Jun 2018 00:00:00 EDT 0
<![CDATA[Sr. Medical Director, Pharmacovigilance]]> Senior Medical Director, Pharmacovigilance

My client is looking for an experienced Sr. Medical Director/Medical Director of Drug Safety and Pharmacovigilance (DS&PV) that is a creative, resourceful and integrative thinker. The Sr. Medical Director/Medical Director serves as the global lead for the pharmacovigilance and risk management of assigned investigational and/or marketed products.   This is a highly visible role that will interface across all levels of management and functional areas and is responsible for identification of safety signals, signal investigation and the proactive management of the benefit-risk profile for assigned products. Effective communication skills will be key as this role provides an excellent opportunity for close collaboration with colleagues from other functions such as Clinical Development, Clinical Operations, Regulatory Affairs and Medical Affairs.

 

Responsibilities:
  • Lead product safety surveillance activities for assigned product(s)during all phases of the product life-cycle
  • Maintain knowledge of therapeutic area diseases and assigned product(s) safety and efficacy profile
  • Ensure that routine signaling activities assessment and investigation are completed and documented per SOPs
  • Respond to safety-related queries from regulatory authorities, IRBs/ECs
  • Lead product benefit-risk assessment discussions at Safety Governance Committee
  • Includes needed actions to update Reference Safety Information or risk minimization actions
  • Lead DS&PV representation for clinical development of the assigned product(s) including:
  • Clinical development plans, protocol development (inclusion/exclusion criteria, collection and monitoring of safety data), statistical analysis and reporting of study data
  • Safety content of IB, Reference Safety Information, ICF
  • Regulatory filings (ISS, Benefit-Risk, RMP/REMS as required)
  • Responsible for medical-safety sections of aggregate safety reports (DSUR, PSUR)
  • Conduct medical review of individual case safety reports (ICSRs)
  • Includes appropriate follow-up requests and accuracy and timeliness of expedited reports
  • Assisting in the successful implementation, execution and maintenance of safety processes and systems that conform to the company’ s business strategy, industry standards and compliance with global regulations

Requirements:
  • MD, MD PhD or MD MPH required
  • Minimum of 3-7 years’ experience in drug safety and/or clinical research/clinical safety experience in the pharmaceutical industry
  • Sound clinical acumen and decision making
  • Ability to review, synthesize and analyze and communicate (verbally and in writing) complex safety data and clinical/pharmaceutical information
  • Expertise in international regulations governing drug safety (US and EU) for pre and post-marketing
  • Level will be commensurate upon experience and qualifications.
  • Prior experience contributing to the development (process improvement, training, etc.) of a drug safety department would be desirable

 
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Wed, 20 Jun 2018 00:00:00 EDT 0
<![CDATA[Director, Program/Project Management ]]> With a successful on-market treatment and an industry-leading pipeline, our client is seeking an individual who will work closely with internal cross-functional teams to ensure clarity of strategy, to manage specific product development and major regulatory submissions (e.g., NDA, MAA), in order to advance pipeline programs on behalf of the company. The successful candidate should possess a scientific background and demonstrate understanding and experience in drug development and the regulatory requirements to plan, execute and deliver both NDAs and INDs to global regulatory authorities.

This role is highly cross-functional, and may involve close interaction with external partners. The Director of Program Management is charged with having an in-depth understanding of critical path/activities and interdisciplinary connections necessary to complete specific major regulatory submissions. The ideal candidate has strong communication skills, ensuring that all team members understand priorities, objectives, deliverables, interdependencies and timelines.

Job Responsibilities:
  • Build, drive and maintain project and major regulatory submission plans that delivers tangible results in advancing the company’ s pipeline, ultimately leading to commercial launch of key assets.  
  • Facilitate team meetings and operational mechanisms to drive cross-functional communication, decision making, and successful execution of program plans and major regulatory submissions.
  • Develop and maintain detailed program and major regulatory submission milestones and oversee the process for content draft, review and delivery according to identified timeline proactively identify and prioritize program risks, and develop and monitor risk mitigation/contingency plans.
  • Oversee adherence to program budgets and regulatory submission project plan timelines and deadlines.
  • Manage interdependencies across functions, including clinical, non-clinical, regulatory and CMC to support execution of project plan and major regulatory submissions.
  • Lead data-driven decision-making in order to make timely, solid, objective recommendations for continuation, acceleration, reprioritization, redesign or termination of projects, along with necessary change management recommendations.
  • Provide periodic status reports to project executives and coordinate documentation and archiving of project deliverables
  • Communicate effectively to team members and executives through written, verbal and project summary updates, providing line of site to key issues and accomplishments


Qualifications/ Requirements: 
  • Demonstrated ability to drive projects to completion
  • BS in technical discipline, Advanced degree preferred
  • 10+ years’ experience in Pharmaceutical industry process and regulations in a function such as clinical, CMC, quality, or regulatory affairs with significant exposure to global teams
  • 5+ years of experience in program management/leadership of cross-functional teams
  • Proven ability to balance conflicting priorities across multiple programs, and to make sound recommendations for trade-offs between resources (personnel, investment, capacity) to achieve aligned corporate objectives with a “ sense of urgency”
  • Self-directed individual who can work both independently and through a cross-functional team in a fast-paced environment, fostering open communication, mutual understanding and cooperation within the company and with external vendors
  • Solution-based thinker with a “ can do”/” do-what-it-takes” attitude, coupled with superb organizational and communication skills
  • Strong interpersonal skills with the ability to motivate others and direct activity from a position of informal influence, negotiate during conflict situations, and forge consensus between competing points of view
  • Fluency with standard computer software packages (Word, Excel, PowerPoint, MS Project, PMIS)
  • Represents attributes reflective of company Values: Patient focused, bias for action, commitment to excellence, empowered people, and integrity.
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Fri, 15 Jun 2018 00:00:00 EDT 0
<![CDATA[Sr. Medical Writer]]> As an integral part of the clinical team, the Senior Medical Writer independently develops and delivers high quality, strategically aligned clinical and regulatory documents. The Senior Medical Writer is responsible for ensuring high quality with regard to scientific content, organization, clarity, accuracy, format, consistency, and adherence to regulatory and internal guidelines, styles, and processes. The Senior Medical Writer must be able to work effectively in a team environment and must have strong scientific, interpretive, organizational, and project management skills.

Primary Responsibilities Include:
  • Plan, prepare, write, edit, format, and finalize clinical and regulatory documents. Documents will include, but are not limited to: clinical protocols, clinical study reports, Investigator’ s brochures, Module 2 summaries of registration dossiers, annual updates to regulatory submissions, briefing books, risk management plans, and regulatory responses.
  • Coordinate the internal review and approval of documents.
  • Effectively collaborate with Clinical Research and Development colleagues, along with other  departments including, but not limited to, regulatory, safety, biostatistics, clinical operations, medical affairs, and the commercial group.
  • Represent Medical Writing on project teams and, as such, advise teams on content and format requirements for various documents, as well as coordinate writing activities for document development (eg, timelines and review/revision responsibilities) with the project teams.
  • Coordinate deliverable with external vendors.
  • To ensure compliance, remain informed on regulations and developments in medical writing, as well as maintain knowledge of product areas, current trends, and current literature.

Requirements:
  • Excellent writing skills
  • Minimum of a Bachelor’ s degree with 8 to 10+ years of industry experience as Medical Writer
  • Ability to understand and interpret clinical and scientific data; ability to define data presentation to meet key messages constructed by a cross-functional team
  • Knowledge of current regulatory requirements and guidelines applicable to GCP/ICH/eCTD compliant documents
  • Previous experience with NDAs/MAAs with active contribution in planning, preparation, and writing of clinical and regulatory documents
  • Ability to multitask, deal with competing priorities, and meet aggressive timeline expectations
  • Experience in working with cross-functional teams
  • Excellent interpersonal and communication skills
  • Flexibility/adaptability to work in a fast-paced and dynamic environment

 
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Fri, 15 Jun 2018 00:00:00 EDT 0
<![CDATA[Clinical Research Associate]]> Join our clients Clinical Development Operations (CDO) team by contributing to the overall success of our novel gene therapy approach. Reporting to a Sr. Clinical Trial Manager of Clinical Development Operations, you will be responsible for supporting two global Phase 3 clinical studies. In this role you will be a key team member who will effectively organize and assist in the implementation, management and close-out of the Phase 3 clinical trials to support Regulatory filings, with a focus on inspection readiness.

Job Responsibilities:
  • Provide overall program support to the CDO team as well as liaise with other internal and external collaborators to execute on bluebird’ s clinical studies
  • Assist with the QC review and creation of site and monitoring related trial documentation (e.g., consent forms, study manuals/forms, training materials, monitoring plans)
  • Assist with the development of CRA and site training materials and ensure all study metric trackers, contact lists, checklists and systems are up to date
  • Track clinical data entry expectations against timelines, including data cuts as appropriate
  • Assist with the oversight of vendors including CROs, Central Labs and independent contractors; actively participate in development of study manuals
  • Responsible for oversight and maintenance of Central Files (eTMF), including ensuring files are inspection-ready for filings
  • Communicate with CROs and/or study sites to support accurate completion, retrieval and review of all regulatory documents and site status/contact information
  • Perform monitoring oversight visits both independently and as a co-monitor to oversee the contracted CRA including site initiation, routine monitoring and close-out visits in accordance with monitoring plans
  • Oversee site compliance with study protocols, GCP/ICH, applicable regulations prior to, during and following visits.
  • Work with site personnel and study team to resolve issues as needed
  • Play key role in the review of study specific data review, including tables, listings and figures
  • Plan and organize study related meetings; take detailed notes at meetings on decisions and action items and distribute the list to the team in the form of minutes
  • Know the stage of all study activities and communicate details to ensure that all team members are kept informed and aware of action items that will impact their tasks
  • Review a percentage of monitoring visit reports as outlined in the monitoring plan and escalates any issues identified to the Clinical Trial Manager
  • Track progress of enrollment, deviations and data entry for assigned sites and across the study; assess trends in effort to communicate issues/resolutions to the broader study teams
  • Acts as liaison between different ancillary groups in the creation of documents when communicating with resource providers outside the project team
  • Participate in the development and review of SOPs, Work Instructions and Administrative References
  • 10-25% travel may be required


Qualifications:
  • BA/BS in a life science or nursing preferred, with at least 3 years of experience in clinical operations, working in the biopharmaceutical or CRO industries, and previous monitoring experience
  • Proficiency in the entire Windows Suite (MS-Project a plus)
  • Experience with eTMF and Quality Management Systems - Veeva experience preferred
  • Solid working knowledge of the processes involved in clinical studies following Good Clinical Practice (GCP) and the Code of Federal Regulations is required. A broad understanding of essential study documentation is critical and experience in both US and EU/ex-US studies a plus
  • Prior experience supporting Regulatory filings and inspections and audits desirable
  • Demonstrates a drive for solutions, a strong sense of urgency, keen attention to detail, and the ability to plan, organize and successfully execute in an environment under time and resource pressure
  • Ability to foster relationships with vendors, clinical sites and colleagues based on trust and collaboration
  • The ability to support several projects simultaneously, an adaptive working style and a creative and thoughtful approach to problem solving
  • Thrives in a fast-paced and evolving environment
  • Independently motivated and able to manage multiple projects with minimal supervision to deliver on time and with high quality
  • Excellent and transparent communication skills and ability to influence across multiple functions
  • Positive, outgoing and collaborative attitude with a passion for helping patients using innovative science
  • Be ready to embrace the principles of the culture
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Thu, 14 Jun 2018 00:00:00 EDT 0
<![CDATA[Associate Director, Medical Writing]]> Our client is seeking an Associate Director, Medical Writing. Reporting to our Vice President, Medical and Technical Writing, the primary deliverables for this role are clinical regulatory documents according to applicable regulations. It is envisioned that this person will play a leadership role in future key regulatory submissions to the FDA and EMA. This will be full time, onsite role.

Job  Responsibilities:
  • Provide leadership in planning and completing key submission documents (e.g., Clinical Summaries of Safety and Efficacy, Clinical Overview) for submissions to the FDA and EMA
  • Contribute to overall project management and to cross functional working groups (clinical operations, clinical development, data management, statistics) as needed to facilitate efficient development and finalization of clinical, nonclinical and regulatory documents for submissions
  • Manage the work of CRO contract writers, as needed
  • Work with the clinical and regulatory teams to prepare protocols, clinical study reports, Investigator’ s brochures, safety updates, and IND clinical sections in CTD format under strict timelines
  • Participate in recruiting and mentoring of staff, and budget planning


Requirements:
  • PhD in a Life Science or equivalent
  • At least 5 years in medical writing, including participating in submissions to the US FDA (NDA, BLA) and EMA (MAA)
  • Experienced in the preparation of protocols, study reports, investigator brochures, safety updates, and IND clinical sections
  • Demonstrated ability to communicate and write clearly, concisely, and effectively
  • Well-organized: ability to prioritize tasks, to work simultaneously on multiple projects, and to complete high? quality documents according to tight timelines
  • Wide knowledge of biologics development, clinical research, study design, biostatistics, the regulatory environment, and medical terminology
  • Proficient in Microsoft Word; familiarity with Excel, QUOSA, and PleaseReview an advantage
  • Accurate and detail-oriented
  • Aptitude for compilation, analysis, and presentation of data
  • Independently motivated, and good problem-solving ability
  • Ability to work with multiple contributors to produce a final unified document
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Thu, 14 Jun 2018 00:00:00 EDT 0
<![CDATA[Senior Clinical Trial Manager]]> Reporting directly to the Head of Clinical Development, the Senior Clinical Trial Manager will lead the planning and manage the implementation of early and late phase clinical research studies, including creating and managing study timelines, budgets and study management plans in a fully outsourced model.

If you are looking for a highly visible, high impact role that comes with mentorship from, and exposure to, the highest levels of the organization, it is a great time to join this growing team. You will have the opportunity to not only learn and execute clinical operations in a fast paced, collaborative environment, but to help shape and define it!

This role provides oversight of Clinical Research Organizations (CROs) and other vendors and may author, review and approve various study related documents and plans. This role will also manage Investigator Sponsored Trials. This position will help review/develop Clinical Operations processes and procedures for a growing department.

Responsibilities:
  • Managing the study team to design, develop, execute and deliver clinical studies in accordance with clinical development plans/strategy and timelines
  • Leading the evaluation, selection, and oversight of CROs and other external vendors to ensure successful clinical trial implementation and execution
  • Anticipating, recognizing and resolving issues; as necessary, managing escalation of study related issues with management and other R&D functions
  • Contributing to the writing and review of clinical documents such as protocols, informed consent forms, investigator brochures, monitoring plans, trial reports and DSURs
  • Reviewing and approving study-related plans generated by CROs and vendors, and ensure the documentation is in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies
  • Ensuring audit-ready condition of clinical trial documentation including the trial master file
  • Reviewing monitoring reports to ensure quality and resolution of site-related issues
  • Serving as liaison with clinical site staff and Investigators as appropriate to ensure optimal Sponsor-site relationships
  • Leading the planning and conduct of investigator’ s meetings
  • Monitoring progress of clinical study activities and reporting on the progress of assigned clinical trials including budget and timelines
  • Performing occasional and periodic visits to sites and/or CROs to assess progress of studies/protocol compliance
  • Participating in the preparation and review of SOPs

Requirements:
  • Bachelor’ s degree is required. Scientific/health care field preferred, but not required.
  • Minimum of 6 years in clinical development in pharmaceutical/biotech industry, at least 3 years of expertise in clinical trial management
  • Thorough knowledge of FDA and ICH GCP guidelines to ensure the appropriate conduct of clinical studies globally
  • Experience in orphan indications and/or stem cell transplantation will be favorably considered
  • Extensive experience managing complex protocols, CROs, budgets, and timelines
  • Experience monitoring clinical studies and conducting SQVs, SIVs, IMVs, and COVs preferred
  • Strong verbal and written communication skills including clinical authoring experience
  • Ability to organize and manage multiple priorities in a fast-paced, entrepreneurial environment
  • Proven track record of effective leadership with excellent organizational skills and ability to work independently
  • Strong interpersonal skills to interact with investigators, vendors, and individuals at all levels of the organization
  • Must be willing to travel both domestic and international
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Mon, 11 Jun 2018 00:00:00 EDT 0
<![CDATA[Associate Director, Program/Project Management]]> This individual will work closely with internal cross-functional teams to ensure execution of the strategy managing specific projects/programs, and facilitating all stakeholder communication. The ideal candidate will have a scientific background, experience with drug development and operations. This role is highly cross-functional, and will involve close interaction and collaboration with external partners. The individual should possess an in depth understanding of cross-functional R&D projects, and will be responsible for creation of project plans, identifying and tracking critical path/activities, risks, contingencies and alternatives. The Associate Director/Director, Program /Project Management will proactively manage daily program/project management activities, including schedule development by function and integration across projects and programs, budget, communication, status reporting, and resource plan development for certain selected larger projects. The ideal candidate will drive alignment to overall priorities, objectives, deliverables, interdependencies and timelines to remain on track by executing against pipeline strategic plan.

Responsibilities:
  • Serve as project manager for drug development teams with focus on PMO platform and Gene Therapy, providing leadership, coordination, and cross-functional communication to enable teams to meet their aligned goals through improved, cross-functional decision making
  • Lead cross-functional program teams (for multiple drug candidates), including representatives from clinical, nonclinical, regulatory, and CMC, to execute on the drug development strategy
  • Identify and track all CMC projects requiring cross-functional support
  • Provide focus for the cross-functional team through visibility to an integrated project plan to ensure all stakeholders are aware of key program activities; to frame important strategic and tactical issues and contingencies; and to ensure timely decision-making
  • Work closely with all team members to apply project management processes such as definition, initiation, planning, execution and risk management.
  • Integrate Analytical Chemistry, Process Development, Manufacturing, Supply Chain, Clinical, Quality, and Regulatory requirements and constraints into overall project plans
  • Lead data-driven decision-making in order to make solid, objective recommendations for continuation, acceleration, reprioritization, redesign or termination of projects, and change management recommendations.
  • Develop and maintain detailed program milestones and timelines, proactively identify and prioritize program risks, and develop and monitor risk mitigation/contingency plans
  • Facilitate team meetings to drive cross-functional communication, decision making, and successful execution of program and accountability to commitments and timelines
  • Apply Project Management best practices, from development of agenda, to distribution of meeting summaries, to follow up of all relevant action items
  • Proactively identify opportunities for improvement to team effectiveness, processes, communication and/or program outcomes
  • Report on program progress/change and elevation of issues/delays, as appropriate, to management
  • Ability to draft slide decks and dashboards for program strategy reviews, Executive, and BoD updates.
  • Understand and leverage inter-department dependencies and handoffs
  • Foster strong relationships with team members and functional line managers, and serve as key point person for program team members on project-related communications and issue identification and management
  • Program budget tracking (together with finance representative), including approval of changes that arise throughout the year due to changing conditions/plans within the program


Qualifications/Requirements:
  • BS in technical discipline, Advanced degree preferred
  • 5-10 years’ experience in Pharmaceutical industry process and regulations in a function such as clinical, CMC, quality, regulatory affairs or project management with significant exposure to global teams
  • Proven ability to balance conflicting priorities across multiple programs, and to make sound recommendations for trade-offs between resources (personnel, financial investment, manufacturing and organizational capacity) to achieve aligned corporate objectives with a “ sense of urgency”
  • Self-directed individual who is able to work independently with limited direction while working successfully in a cross-functional environment.
  • Must be a solution-based, creative thinker with a “ can do”/” do-what-it-takes” attitude and superb organizational and communications— both written and oral
  • Demonstrated leadership in clinical-stage drug development settings with strong analytical skills and entrepreneurial drive
  • Highly collaborative team player who fosters open communication, facilitates mutual understanding and cooperation with all stakeholders
  • Strong interpersonal skills with the ability to motivate others, to direct activity from a position of informal influence, to negotiate conflict situations, and to forge consensus between competing points of view
  • Must have the ability to work well as part of a team in a fast paced environment and foster open communication, mutual understanding and cooperation within the company and with external vendors
  • Fluency with standard computer software packages (Word, Excel, PowerPoint, MS Project, PMIS, etc.
  • PMP certification preferred
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Tue, 05 Jun 2018 00:00:00 EDT 0
<![CDATA[Associate Director / Director, Pharmacovigilance Operations]]> This position serves the primary focus of creating the global Pharmacovigilance (PV) department and will be responsible for the PV Operations activities globally across all products in clinical development and on the market. The incumbent will be joining the growing PV department and be an integral member of the PV leadership team reporting directly to the Vice President and Head of PV.

Responsibilities include a strategic and tactical approach to management and oversight of the company’ s PV Operations processes for both investigational and marketed products in compliance with internal SOPs and applicable global regulations and guidelines. This person needs to be highly motivated and is expected to provide innovative, critical, and strategic input and leadership.

Primary Responsibilities:
  • Manage the PV Operations function.
  • Organize and oversee the receipt, evaluation, processing, documentation and reporting of adverse event information from clinical trials, investigator sponsored trials, post-marketing, etc. sources.
  • Manage and oversee PV vendor. Monitor performance and compliance.
  • Support ongoing safety surveillance of company products.
  • Contribute to regulatory submissions, aggregate reports, investigator communications, labeling, etc. as needed.
  • Develop and implement PV training programs for internal and external needs and monitor compliance.
  • Provide safety and pharmacovigilance expertise in-house for products in development and marketed products.
  • Oversee preparation and quality control activities for safety case processing activities performed internally and by vendors or contractors.
  • Lead development of standard operating procedures for safety and internal compliance
  • Manage license partners, vendors, etc. with PV Agreements and Safety Data Exchange Agreements.
  • Liaise with other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Manufacturing, and Legal.
  • Support the Head of Pharmacovigilance develop and implement appropriate drug safety programs and processes

Requirements:
  • Healthcare degree in nursing or pharmacy
  • Minimum 10 years’ experience in PV operations
  • Ability to build relationships and influence across disciplines and all levels
  • Global experience is required.
  • Occasional travel required.
  • Thorough knowledge and understanding of global regulations for safety and pharmacovigilance including FDA, EMA and ICH guidelines.
  • Knowledge of MedDRA, WHO DD
  • Experience with Argus and ArisG

 
]]>
Tue, 05 Jun 2018 00:00:00 EDT 0
<![CDATA[Senior Clinical Data Manager]]> As a member of our growing Data Management team, you will significantly contribute to the success of the DM function by having a large impact and leading the DM tasks on assigned projects.  You will work with a team-oriented and dedicated group who will welcome your innovative ideas while motivating and challenging you along the way.

This position works with clinical, biostatistics, and contract research organizations (CROs) to ensure that data management activities are performed with quality according to project timelines.  This position will manage all data management activities from CRF design through database lock for in-house and outsourced clinical trials with minimal supervision.

Responsibilities:
  • Independently lead and represent Data Management (DM) for all DM activities of an assigned study or assigned studies within a program 
  • Initiate, facilitate, lead and document all DM project management activities, e.g. DM deliverables, DM meetings, minutes
  • Establish rapport and maintain positive, open communication with internal and third-party teams
  • Mentor, lead and provide DM guidance to junior level DM team members
  • Will delegate DM activities to junior level staff as needed for assigned studies and independently perform ongoing data quality reviews, provide training and direct study team members to ensure data quality
  • Will be the DM subject matter expert for DM process questions from CROs, third party vendors and cross functional areas, e.g. Clinical Operations, Medical, Biostatistics, Programming, PVG, IT
  • Will review upcoming DM deliverables and forecast resourcing requirements as needed to execute ongoing and upcoming DM activities within timeline and budget requirements
  • Participate in reviewing requests for proposals (RFPs) and providing budgetary, contractual and scope of work (SOW) feedback for the DM functional area
  • Able to execute all activities required of the Senior Clinical Data Manager position:
  • Works with clinical, biostatistics, and CROs to design and develop study documents including Case Report Forms (CRFs), CRF Completion Instructions, Data Management Plan (DMP), Database Specifications, Electronic Edit Checks, and Data Transfer Specifications in CDISC format
  • Manages the CROs to ensure that outsourced data management tasks remain on target according to project timelines and within budget
  • Manages third party vendors including review of data transfer specifications, managing data deliverables, reconciliation and ensuring quality transfers on time and within budget
  • Proactively organizes ongoing data review within clinical and biostatistics throughout the conduct of the study to ensure timely and appropriate identification of errors and discrepancies

Oversee and perform, as necessary, the following tasks:
  • Serve as the primary point of contact for DM functional area
  • Drive study setup, maintenance and lock activities
  • Plan and perform user acceptance testing of clinical database (CRF and edit checks)
  • Generate, review and approve data management plans
  • Review and approve data transfers and other deliverables from external sources
  • Lead cross-functional discussions to define data handling and database design standards
  • Define and manage timelines to meet deliverables on time and with quality
  • Generate and disseminate project status reports to management
  • Manage CRO/data management specific vendor activities, timelines, and budgets
  • Participate in data management initiatives such as evaluate technology vendors (i.e. EDC, analytic tools), author and review SOPs, and establish data collection and reporting standards


Qualifications:
  • Minimum 5 years of experience in CRO, Pharmaceutical or Biotech Clinical Data Management and 2 years as a Lead CDM
  • Knowledge of the clinical trial process, ICH GCP, and applicable health authority regulations
  • Experience with Medidata RAVE, SAS and Coding tools
  • Awareness and familiarity of statistical methodology
  • Ability to solve complex problems in all areas of data management
  • Effective communication skills, both verbal and written
  • Strong attention to detail
  • Bachelor’ s degree required 
]]>
Thu, 31 May 2018 00:00:00 EDT 0
<![CDATA[Senior Associate, Regulatory Operations]]> The Senior Associate, Regulatory Operations is responsible various day-to-day functions related to document publishing, regulatory information management, and submission management among other tasks as required. Under the direction of the Director, Regulatory Operations, this individual will support various regulatory application types including INDs, NDAs and related amendments/supplements in eCTD format. The successful candidate will ensure submissions and related documentation are prepared in compliance with various health agency regulations and guidelines. This role will coordinate and liaise with external submission vendors to manage submission compilation, validation and dispatch.

Responsibilities:
  • Electronic document publishing, scheduling and coordination of various document complexities (clinical protocols/amendments, nonclinical reports, SAPS, CSRs, related regulatory documentation, etc.)
  • Support various internal functional groups ensuring the compliant use of eCTD Authoring Templates
  • Primary user of Adobe Acrobat, 3rd-party plugins, eCTD Authoring Templates and related tools as required
  • Ensure tracking and archiving of regulatory filings, correspondence and related information for various regulatory applications
  • Perform U.S. and international regulatory research tasks as related to Regulatory Technology and Operations
  • Attending internal team meetings to collect and organize potential upcoming publishing and submission tasks
  • Participate in Regulatory initiatives aimed at improving internal regulatory standards, systems and procedures
  • Participate in creation, review and implementation of department SOPs, WIs, guides and checklists
  • Special projects related to submissions metrics in the form of tracking, collating, analyzing and reporting of key submission statistics
  • Support ongoing eDMS reconciliation activities
  • Help drive eDMS initiatives, functionality testing and training efforts
  • Assist with other Regulatory and adjacent technology projects, as required


Qualifications:
  • 5+ years of direct Regulatory Operations experience publishing, compiling, QC, Validating and coordinating electronic submissions
  • Electronic document publishing and eCTD experience is required
  • Microsoft Office Suite (key focus on Word, Excel and PowerPoint and Visio, Adobe Acrobat, TRS Toolbox (formerly ISI), archiving/ filing/RIM activities, Veeva Vault and authoring template experience highly desired
  • eCTD viewing, validating, and general regulatory submission project management experience preferred
  • Excellent verbal and written communication skills required
  • Ability to work in a fast-paced environment that is primarily timeline-driven
  • Ability to independently complete complicated and technical tasks using sound judgement within stated request period as well as work as part of a team environment
]]>
Thu, 31 May 2018 00:00:00 EDT 0
<![CDATA[Receptionist/Executive Assistant]]> Individuals and businesses that partner with this organization are diverse and often have complex needs. As an Executive Assistant/Receptionist, you will play an integral role with the entire organization, particularly the Sales and Management Team. You will work under the direction of the President & CEO primarily but also substantively with the Chief Operating Officer. The ideal candidate will have a strong background as an Executive Assistant so as to enhance the executives' effectiveness by providing critical support and representing the executives to others.

You need to be proactive, able to multi-task in a fast-paced environment, and Client Service focused to help maintain good Client relationships both externally and internally.

Job Responsibilities
  • Support President & CEO on a daily basis; producing information by procuring, formatting, inputting, editing, copying, scanning, and transmitting information of all types
  • Optimizing executives' time by reading, researching, and routing correspondence; drafting letters and documents, collecting and analyzing information as well as initiating telecommunications
  • Maintaining President & CEO' s appointment schedule by planning and scheduling meetings, conferences, teleconferences and travel
  • Reviewing and commenting on Salespersons' monthly expense reports
  • Attending Sales Strategy Team Meeting (SST) every month, taking notes and transcribe notes into a report, attending other meetings as scheduled
  • Following-up with Producers on Sales Track Program
  • Maintaining and completing insurance carrier appointment requirements
  • Maintain and keep track of licensing for President & CEO
  • Welcoming guests and customers by greeting them, in person or on the telephone, answering or directing inquiries

Receptionist Duties:
  • Greet and direct visitors to appropriate staff (after calling to advise of, and identify visitor)
  • Answer incoming calls
  • Take and promptly deliver clear, concise messages when required
  • Page when necessary & Greet Clients, Vendors, etc.
  • Enter Client, Vendor and Carrier Business Cards in Microsoft Outlook
  • Send for Messenger Services, sign for delivery of packages
  • Update directories:  Telephone listing, Team Divisions, Anniversaries, Birthdays
  • Route faxes
  • Sort and distribute all incoming mail for Alper Team Members, and date stamp incoming and outgoing mail


Qualifications/ Requirements:
  • Education:  College Degree preferred or equivalent work experience.
  • Experience:  3-5 years’ administrative support in business environment or other related services industries required.

Preferred Qualifications: 
  • Discretion and confidentiality
  • Exemplary planning and time management skills
  • Ability to prioritize and multi-task efficiently
  • Ability to work effectively under pressure to meet deadlines
  • Extensive written and verbal communication skills
  • Ability to work in Team setting
  • High energy level
  • Good interpersonal skills
  • Must be flexible and work independently
  • Working knowledge of Microsoft Word, Excel, Outlook and Power Point
  • Experience with AMS360 or similar agency management system
]]>
Wed, 30 May 2018 00:00:00 EDT 0
<![CDATA[Associate Director, Regulatory Labeling and Ad Promo]]> Responsibilities:
  • Facilitate and Lead the development, review, approval, and maintenance of the US Package Insert (PI) and Summary of Product Characteristics (SmPC) components for assigned products either globally as a Global Labeling Lead or regional/local as a Regional Labeling Lead
  • Serve as an internal expert on FDA regulations, guidance and enforcement trends governing prescription drug promotion
  • Assess promotional materials to evaluate their completeness, accuracy and compliance with the Office of Prescription Drug Promotion (OPDP) requirements
  • Establish and maintain interactions with FDA regarding promotional materials review and approval
  • Act as a Subject Matter Expert (SME) on local, regional and multi-country regulatory labeling requirements and participate in the sharing of intelligence.
  • Follows Global Labeling procedures and maintains document management systems for assigned products.
  • May develop and implement policies and operational targets
  • May have responsibility for management of employees that may be added to the department.
  • Technical expert with sufficient expertise and experience to be considered for sensitive and/or complex assignments
  • Authors and maintains core labeling documents including Core Data Sheet (CDS), core Patient Information Leaflet (cPIL), core Instructions for Use (cIFU), development Core Data Sheet (dCDS), development Core Instructions for Use (dIFU), and United States Prescribing Information (USPI).
  • Manages compounds with a high degree of complexity from a labeling perspective.
  • Chairs/leads Labeling Working Group and presentations to Cross-Functional Executive Labeling Board meetings.
  • Advises internal and/or external experts on the creation of high quality documents supporting changes to the core labeling documents and manages the annotations within those documents.
  • Provides strategic labeling advice for major regions and works with cross functional teams to ensure that the execution of global regulatory labeling plans are aligned with global regulatory strategies.
  • Provides input and strategic guidance to the Target Product Label.
  • Reviews and provides feedback and approves deviations from core labeling.
  • Ensures deviations from labeling procedures and policies are escalated appropriately.
  • Assists in preparation of responses to labeling-related Health Authority queries.
  • Manages the review and approval of core Dear Health Care Provider (DHCP) letters.


Qualifications:
  • Minimum MS degree or higher in life science.
  • 7+ years of regulatory labeling and Ad Promo experience within the pharmaceutical and biotech industries.
  • Experience in US and global regulatory labeling and Ad Promo environments is preferred.
  • Demonstrate a solid working knowledge of drug development process, as well as FDA and EU labeling
  • Competent knowledge of and demonstrated ability to apply regulatory guidelines pertaining to product labeling and ICH guidelines.
  • Demonstrate strong project management, people management, problem solving, strategic thinking, negotiation, interpersonal and communication skills (both written and oral) attention to detail and ability to work under tight timelines.
]]>
Wed, 30 May 2018 00:00:00 EDT 0
<![CDATA[Director, Regulatory Affairs]]> Our client is seeking a Director, Regulatory Affairs to lead the preparation of regulatory submissions to assure full compliance with all relevant requirements in the U.S. as well as in Europe, Canada, Japan and Australia.

Responsibilities:
  • Provide strategic and operational input, guidance and oversight to global project teams to assure that regulatory submissions and all aspects of regulatory compliance support R&D objectives.
  • Develop and create regulatory compliance strategies for multiple clinical development projects.
  • Coordinate all aspects of the preparation, review and submission of regulatory documents.  This includes the clinical and non-clinical portions of documents.
  • Represent the Regulatory Affairs Department as a member of cross functional project teams and provide guidance relating to changing global regulatory requirements.
  • Serve as the Company’ s Regulatory Affairs Lead in interactions with global health authorities including the FDA, EMA, MHRA, Health Canada and ROW with respect to clinical submission documents.
  • Provide leadership and direction in the development of clinical regulatory documents including INDs, CTAs, BLAs, DMFs, NDAs and MAAs.
  • Make submissions to global regulatory authorities, as required, and maintain an ongoing interactive relationship regarding these submissions.
  • Coordinate and maintain reporting schedules for regulatory applications.
  • Assure that all aspects of the Company’ s regulatory activities are conducted in full compliance with applicable regulations and at the highest level of ethical standards.
  • Create and maintain Regulatory Strategic Development plans and provide strategic input in global product development planning.
  • Identify and communicate to executive management information about potential regulatory issues; propose risk evaluations and mitigation strategies.
  • Mentor and help develop the strategic & technical expertise of regulatory colleagues who are involved in supporting filings.

Requirements:
  • Bachelor’ s degree in a relevant scientific discipline.  Master’ s or an advanced degree (PhD, PharmD) is preferred.
  • 15+ years of regulatory affairs experience in the pharmaceutical industry.
  • Understanding of global regulatory submissions including compliance with FDA, EMA, ICH and ROW clinical and preclinical regulatory requirements.
  • Relevant filing experience (INDs and NDAs) in leading negotiations and Health Authority interactions as well as FDA Advisory Committee Meetings (e.g. ODAC).  Experience with regulatory filings in oncology is preferred.
  • Strong written and oral communication skills and the ability to interact effectively with project teams.
  • Ability to manage regulatory affairs activities and provide leadership in a “ hands-on fashion” while utilizing a strategic approach in all aspects of global compliance.
]]>
Tue, 29 May 2018 00:00:00 EDT 0
<![CDATA[Senior Director, Regulatory Affairs]]> Our client is seeking a Sr. Director, Regulatory Affairs. As a member of the program teams, they will provide strategic guidance regarding FDA and ex-US regulatory requirements for global clinical development and registration of pharmaceuticals.

Responsibilities
  • Compile, review, approve and submit clinical trial and marketing registration applications, amendments, and supplements.
  • Manage and ensure compliance with all reporting requirements, including annual and periodic reports.
  • Organize and manage regulatory meetings with health authorities.
  • Review materials for compliance with advertising and promotion regulations.
  • Perform regulatory strategic assessments for new product candidates and new indications.
  • Provide strategic guidance for and author applications related to designations for expedited programs (e.g. Fast Track, Breakthrough, Priority) or special status (e.g. Orphan).
  • Manage contract staff and vendors as needed to support regulatory activities.
  • Provide create and innovative solutions while being an advocate for compliance.


Requirements:
  • 10-15 years of experience in Regulatory Affairs related to development of pharmaceuticals, CNS experience preferred
  • Bachelor of Science in a scientific discipline, MS or PhD preferred
  • Strong knowledge of eCTD elements and structure
  • Strong regulatory writing skills and use of Microsoft Word
  • Experience working with all levels of management and consulting with key business stakeholders. An ability to influence for greater outcomes.
  • Strong team player that has a customer service approach and is solution oriented.
  • Attention to detail and the ability to work individually, within a multi-disciplinary team, as well as with external partners and vendors.
  • Possesses strong written and verbal communication skills.

 

 
]]>
Tue, 29 May 2018 00:00:00 EDT 0
<![CDATA[Sr. Medical Director, Surveillance and Risk Management]]> Our client is seeking a Sr. Medical Director, SRM and they will serve as the global lead for surveillance and risk management of all products marketed and in development.   This key position will lead a team of medical doctors and PV scientists, and interact across functions and at various management levels. The head of SRM and his/her team are responsible for the detection and investigation of safety signals, assessment of the need for risk mitigation activities, and the continuous benefit risk evaluation of all products. This role will interact with senior management and closely collaborate with colleagues from other functions such as Clinical Research, Regulatory Affairs, Data Science, Medical Affairs, Clinical Operations.

Job Responsibilities:

Key responsibility is to build and lead a high performing team of medical safety experts to:
  • Medically assess ICSRs from development and post-approval sources
  • Have an in depth understanding of product’ s safety profile as well as the patient profile in approved or studied indications
  • Monitor patient safety in clinical trials, in close collaboration with Clinical Research and Data Sciences
  • Lead Safety Management Teams
  • Evaluate safety data from various sources, including literature, clinical trials, internal and external safety databases. Propose proactive PV Strategies.
  • Apply, or introduce best industry practices to safety surveillance, including signal detection and assessment as well as benefit-risk evaluations.
  • Apply sound judgment in matters of recommended actions including label updates, risk mitigating activities and communications to health authorities, prescribers or consumers.
  • Produce excellent aggregate benefit-risk reports, and scientifically sound discussions and summaries, in support of decision making
  • Develop and propose post-market risk management plans, risk mitigation strategies as needed and monitor effectiveness

At the individual level, the head of SRM will:
  • Play a key role in the Company Safety Oversight Committee.
  • Interact with health authorities related to safety matters
  • Present to investigators, or other medical or professional audiences
  • Approve regulatory and clinical documents for submission.
  • Present or represent the DS PV position where needed
  • Report to the VP Drug Safety and Pharmacovigilance


Qualifications/ Requirements:
  • MD, DO, or equivalent
  • Minimum of (2) years Clinical experience after medical education
  • Minimum of (10) years industry experience in Pharmacovigilance and Risk Management
  • Track record of successfully leading teams.
  • Track record of successful safety issue management
  • Training or experience in quantitative research, epidemiology, public health
  • Extensive experience in both investigational and post-approval context
  • Board certification is a plus
]]>
Thu, 24 May 2018 00:00:00 EDT 0
<![CDATA[Manager/Sr. Manager, Clinical Operations]]> Leads all aspects of a particular clinical study and demonstrates a high level of knowledge of clinical operations’ methodologies, organizational, project management and leadership capabilities

Works to ensure adherence to a standardized approach to project management

Manages clinical trials projects through leadership of and delegation to a cross-functional study execution team (CST), working under the guidance and direction of an Associate Director, Program Lead.  May rely upon Senior Clinical Project Managers for guidance but acts as a mentor/coach to junior staff.

Ensures successful clinical trial planning, execution and delivery – within specified quality, time and cost parameters

 

Responsibilities:

 
  • Develops a quality control plan for trial master files and then ensures those TMFs are created, maintained, monitored, and closed out on a timely basis
  • Ensures site monitoring reports are accurate and thorough and that metrics are being adhered to
  • Actively participates in the development of department initiatives, including acting as lead on the development /definition of certain SOPs and processes
  • Ensures that an overarching trial cross-functional quality plan is in place
  • Responsible for managing creation, maintenance and close out of TMF activities – e.g. manages Central Lab and ancillary vendors such as IVRS selection, set-up, conduct, and close-out for studies.
  • Oversees and manages vendors (CRO) to ensure that clinical trials are getting the necessary resources and attention the vendor has committed to ensure trial deliverables and performance goals are met.
  • Oversees the development of and adherence to clinical trial project timelines and ensures senior Clin Ops staff, PDT, and FAHs are informed of and understand risks / challenges, which includes putting risk mitigation plans in place, monitoring risk metrics, and communicating those risks
  • Ensures accurate and comprehensive completion of documents needed by Regulatory Affairs; works with RA to establish timeframes and ensure clarity of documentation required; makes sure that completed documents are handed over to RA within the requested timeframes and ahead of submission deadlines
  • Coordinates the relevant and timely exchange of information / materials (e.g., patient enrollment, site selection, and data collection) with other functions (primarily those represented on CST) to support clinical trials delivery within the drug development process
  • Provides regular timely communications to Supply Operations regarding patient enrollment information at sites to support the supply of drug products to patients
  • Ensures that external partnerships (e.g. CRO) are effectively supporting clinical trials, within contracted terms including budget; is the primary point of contact for CRO partners
  • Adheres to clinical trial budgeting process and provides input on process optimization landscape
  • Leads matrix, multi-disciplinary, cross-functional study execution teams (CST) from start-up through close to ensure both internal and external deliverables are on time and on budget
  • Has both an internal and external perspective on clinical trial management; ensures that clinical trials are operationally feasible while understanding the external landscape, including a focus on KOL activity and the competitive Leads cross functional team to ensure timely activation of clinical trials; including risk management and problem-solving
  • Proactively identifies, negotiates and brokers solutions to individual clinical study issues
  • Delegates and oversees the management of certain aspects of project management to CTA and Senior CTA staff to ensure clinical studies at a project level are executed within specified time, quality and cost parameters.

Requirements
  • BA/BS with 5-7 years progressive experience in clinical operations preferably within the biotech, pharmaceutical, CRO, industry
  • Demonstrates ability to provide input into clinical protocol development.
  • Demonstrates ability to manage and execute clinical studies.
  • Demonstrates thorough knowledge and understanding of key regulatory authorities, ICH Guidelines, and GCPs governing the conduct of routine clinical trials.
  • Experience of managing/overseeing CROs/vendors.
  • As a result of being member and project manager of CST, develops detailed understanding of different departments and functions and interdependencies of the functions.
  • Very strong verbal, written and presentation skills are required.
  • Experience of leading of a matrixed cross-functional team.

 
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Thu, 24 May 2018 00:00:00 EDT 0
<![CDATA[Associate Director, Medical Communications and Operations]]>
Job Responsibilities:
  • Execute, manage, and track strategic medical communications information plans
  • Launch and manage medical information functional operations
  • Represent medical communication and information function at internal meetings, congresses, and with vendors, collaborating closely as needed
  • Develop in-depth therapeutic knowledge of disease, epidemiology, product and competitor product information; act as a resource to others external to Medical Affairs
  • Identify, collect, and provide relevant information and input into business activities such as product and competitor insights, medical product plan and deliverables, new business assessments and other requests
  • Serve as authoritative source of medical/ scientific expertise
  • Ensure compliance with company policies and procedures
  • Perform other duties as directed

Qualifications/ Requirements:
  • Advanced scientific degree preferred (PhD, PharmD, APRN) with minimum 5 years of experience within a communications function; oncology experience required
  • Excellent project management required; scientific writing skills experiences preferred
  • Ability to lead initiatives and work with teams cross functionally
  • Knowledge of pharmaceutical industry regulations, guidelines, standards and practices
  • Demonstrated problem solving skills in a matrixed environment and in complex situations
  • Personal Characteristics
  • Hands-on with an attention to details, pro-active with internal stakeholders, and leadership skills complemented by sound business acumen
  • Ability to work in a fast-paced environment with competing priorities
  • Takes initiative and works independently and collaboratively with minimal supervision
  • Ability to read, interpret, and convey complex scientific information
  • Excellent written and verbal communication with customer service mindset
  • Ability to work collaboratively towards a common goal
  • Demonstrated results orientation and problem solving skills
  • Travel requirements: up to 10%
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Thu, 24 May 2018 00:00:00 EDT 0
<![CDATA[HR Manager]]> Support the strategic direction of the company by developing a positive and high performance team culture. This role encompasses the entire range of HR administration and employee relations, implementing and administering policies and programs in recruitment, organizational planning, training and development, employee relations and communications. 

Job Responsibilities
  • Ensure staffing of qualified employees by developing and managing recruitment, interview, selection and on-boarding process, including intern programs.
  • Serve as a link between management and employees by handling questions and helping to resolve work-related issues.
  • Organize and lead HR team at assigned locations by communicating expectations; planning, monitoring work, assessing results; enforcing policies and ensuring quality and productivity standards are achieved.
  • Take lead role in designing and facilitating on boarding programs, including management training and leadership development.  
  • Evaluate and recommend training resources to support employee development. 
  • Administer performance management program.


Qualifications/Requirements
  • Ability to work effectively with all levels of employees and management.
  • Ability to handle multiple projects simultaneously while maintaining quality standards.
  • Excellent organizational, leadership, interpersonal and communications skills.
  • Positive and professional demeanor, cooperative personality with ability to participate effectively in a collaborative team environment.
  • Optimize work of assigned department(s) and balance the work load appropriately; develop and implement efficiencies to improve the work flow; develop and oversee the training, development and evaluation of assigned staff and ensure smooth teamwork with other functions; and, ensure high quality standards are established and maintain
     
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Wed, 23 May 2018 00:00:00 EDT 0
<![CDATA[Director, Regulatory Affairs]]> Responsible for actively contributing to the development and implementation of regulatory strategy for specific projects, executing submissions, serving as the regulatory lead on relevant project teams, and serving as the regulatory contact with relevant regulatory authorities, as appropriate.

Responsibilities:
  • Working in partnership with the Vice President, Regulatory Affairs:
  • Assist in work managing and executing regulatory submissions
  • Responsible for NDA & MMA billed submissions
  • Ensure regulatory compliance with pre- and post-approval filing and reporting requirements
  • Develop response strategies and submissions to regulators
  • Provide regulatory leadership and guidance to project teams, leadership for the development of global regulatory submission documents
  • Develop briefing packages, fast track applications, orphan drug applications for meetings with FDA and other global health authorities
  • Responsible for actively contributing to the development and implementation of regulatory strategy for assigned projects and programs. Contribute to the development and implementation of clinical, pre-clinical and CMC, regulatory strategy for projects in all stages of development (pre-IND/IMPD through commercial).
  • Integrate global regulatory understanding and responsibilities in developing strategy and development of regulatory submission documents
  • Provide regulatory expertise and support nonclinical, CMC and clinical areas for investigational products
  • Ensure clinical, nonclinical and CMC programs are designed and implemented to meet regulatory requirements
  • Define regulatory expectations for project teams
  • Manage or delegate the management of the completion of documents and other assigned tasks within established timelines and with high quality – in terms of scientific content, organization, clarity, accuracy, format, consistency and adherence to regulatory guidelines, styles and processes.
  • Develop strategies and drafts and/or review responses and other documents intended for submission to FDA and other global health authorities
  • Perform as the back-up to VP RA at regulatory meetings and liaison with FDA and other regulatory authorities
  • Responsible for coordinating all aspects of regulatory submissions relevant to assigned projects or programs.
  • Identify and assess regulatory risks for assigned projects or programs.
  • Prepare and deliver effective presentations for external and internal audiences.
  • Contact regulatory agencies relevant to assigned projects or programs, as appropriate.
  • Participate and contribute in Health Authority meetings.
  • Develop and mentor junior Regulatory staff members.


Qualifications:
  • Minimum M.S. degree in life/health/technical sciences required
  • Minimum 10+ years’ regulatory experience or a PhD/PharmD or equivalent with at least 5 years of experience within the biotech or pharmaceutical industry
  • A minimum of 7 years regulatory experience within the drug development and approval process in IND/CTAs/Marketing Applications
  • Knowledge of global regulatory requirements
  • Recent successful NDA experience required, as well as experience within a matrix environment
  • Ability to work both independently with minimal direction and within project teams, committees, etc. to attain group goals.
  • Demonstrate excellent communication skills.
  • Ability to represent the department in project teams.
  • Demonstrate strong organizational skills, including the ability to prioritize personal and direct reports workload.
  • Strong interpersonal skills and the ability to deal effectively with a variety of personnel including medical, scientific, and manufacturing staff.
  • Demonstrated effective cross-cultural awareness and capabilities.
  • Experience in interfacing with relevant regulatory authorities.
  • Experience and knowledge in the preparation of major regulatory submissions and supportive amendments or supplements.
  • Knowledge and understanding of applicable regulations.
  • Experience in interpretation of regulations, guidelines, policy statements, etc.
  • Computer literate.
  • Sensitivity for a multicultural/multinational environment.
]]>
Wed, 23 May 2018 00:00:00 EDT 0
<![CDATA[Associate Director, Medical Publications and Communications]]> Our client is seeking an Associate Director, Medical Publications and Communications. The successful candidate will be responsible for interacting with various investigators, HCPs, vendors, and internal departments to lead publications planning and management for assigned therapeutic area(s) while ensuring compliance with good publication practices and scientific merit of medical publications.

Job  Responsibilities:
  • Work with internal and external authors in actively facilitating the development of abstracts, posters, presentations, original manuscripts, and review papers.
  • Lead cross functional strategic publications efforts in alignment with product development teams to ensure prioritized submission and publication of data to address unmet educational needs.
  • Coordinate medical writing and external vendor activity to ensure timely delivery and submission of publications.
  • Ensure consistent adherence to established  publication process in accordance with good publication practices.
  • Manage assigned publications spend to ensure accurate accounting and reconciliation to available budget.
  • Collaborate with functions inside and outside of Medical Affairs to translate available data and publications into medical communications and educational resources.
  • Partner with Congress Strategy lead and conference planning team to map out oral and poster presentations.
  • Cover poster and scientific sessions at select medical conferences and write debriefs.


Qualifications/ Requirements:
  • This position requires a clinical and scientific background and significant biotechnology/pharmaceutical industry experience in leading publications efforts in a highly matrixed organization.
  • 8+ years in a biotechnology/pharmaceutical environment required. Has attention to detail, excellent communication and project management skills, and proven ability to effectively collaborate and influence decision-making across multiple levels of an organization, including senior leadership.
  • Willing and able to travel for medical conferences as necessary.
]]>
Tue, 22 May 2018 00:00:00 EDT 0
<![CDATA[Sr. Clinical Project Manager]]> Responsible for the planning, implementation, execution and management of multiple clinical studies by overseeing day-to-day operations and directly managing outside Clinical Research Organizations.

Job  Responsibilities:
  • Represents and leads the study team to design, develop and deliver the clinical study to agree upon timelines.
  • Leads planning and communication with cross-functional teams to ensure proper execution and conduct of the clinical trial; generates quality clinical data.
  • Serves as primary contact and resource for CRO and vendor personnel in overarching functions as well as team members in parent company.
  • Provides oversight and management of CROs, consultants and vendors.
  • Oversees and monitors the management of clinical studies ensuring they are conducted in compliance with the agreed study plans through regular CRO and/or investigator site contact.
  • Monitors progress of clinical activity and reports on the progress of assigned clinical trials including budget and timelines.
  • Monitors the status of clinical data collection of assigned clinical trials.
  • Prepares potential investigator site lists and assists with their evaluation for inclusion in the study.
  • Prepares and reviews study-related documents when required.
  • Reviews and approves study-related plans generated by CROs and vendors, and ensures the documentations are in accordance with GCP regulatory requirements and consistent with the protocol for assigned studies.
  • Participates in the review and finalization of clinical study-related documents such as protocols, protocol amendments, clinical study reports (CSRs), regulatory submissions and other publications as required.
  • Participates in meetings – i.e. Study Team Meetings, Investigator Meetings, Monitors’ workshops and CRO Training.
  • Reviews correspondences and monitoring reports relating to the studies.
  • Prepare and deliver program/study updates.
  • Coordinates the delivery of clinical trial supplies in collaboration with CRO and other team members.
  • Monitors budget for clinical study, and review budgets and contracts with CROs, vendors and investigator sites (as applicable) in collaboration with Finance and Legal team.
  • Requests and critically evaluates proposals and change orders from CROs, vendors and investigator sites (as applicable).
  • Provides input into contracts, work orders and/or change orders.
  • Manages escalation of study related issues and communicates as appropriate with management and other R&D functions.
  • Ability to anticipate potential study issues and to prepare contingency plans with minimal oversight.
  • Ensures assigned studies adhere to all applicable regulations and requirements.
  • Provides input as the subject matter expert for the assigned studies during regulatory inspections.
  • Establish collaborative and productive relationships with parent company, internal/external partners and relevant affiliates.
  • Evaluates issues found in clinical studies, communication and oversight of CROs and vendors, and suggests and implements solutions and mitigations as required.
  • Evaluate CRO and vendor performance and support the improvement initiatives.
  • Participate in the preparation, review, updating and training of SOPs.
  • Maintain knowledge of oncology therapeutic area, current medical practice and pharmaceutical regulations in order to ensure best practice across all activities.


Qualifications/ Requirements:
  • B.S./M.S./Ph.D. in a related life science discipline is preferred.
  • Thorough understanding of the oncology arena.
  • Minimum of five years of industry experience in clinical drug or program development or equivalent academic experience in clinical trials.
  • Strong experience facilitating project team meetings, cross-functional communication and decision making, and ensuring alignment with internal and external stakeholders
  • Strong attention to detail and the ability to establish priorities, schedule and meet deadlines.
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Tue, 15 May 2018 00:00:00 EDT 0
<![CDATA[Inside Sales Representatives]]> Our client, a leader in metals distribution and fabrication, is currently seeking Inside Sales Representatives to join their customer service center sales team in Minneapolis, MN. Under the supervision of the Inside Sales Manager, the  primary role as an Inside Sales Representative is to provide sales support across company-wide markets in order to achieve sales growth. You will  provide  excellent service while interacting with customers over the phone and through email. Inside Sales Representatives are responsible for direct sales aimed toward growing the  business overall.  

Job Responsibilities:

• Collaborates  with a variety of industries while promoting transactional and fabrication sales business
• Builds professional relationships with customers across multiple geographic markets
• Responds to customer quotation requests, needs, inquiries, and complaints/concerns
• Generates sales through focused, pro-active marketing; primarily out-reaching
• Processes customer orders (i.e. quotations and order entry)
• Sources for items that are not stocked
• Identifies strategies to improve/grow sales
• Understands and incorporates the goals and concepts of our business to grow sales and profitability
• Works closely with territory managers, credit, inventory, warehouse operations, and other departments within the company
• Performs other duties as assigned

  Requirements:

• Associates Degree and 1-3 years of sales or industry experience
• Previous sales or customer service experience preferred
• Proficiency with Microsoft applications (i.e., Word, Excel)
• Attention to detail
• Ability to skillfully multi-task
• Results-focused, competitive, and self-motivated attitude
• Problem solving/conflict resolution and negotiation skills
• High level of numerical and mechanical aptitude
• Takes ownership of work; understands the importance of creating value/recognizes opportunities
• Ability to work well and excel while working with a team or individually
• Strong interpersonal, written and verbal communication skills

 
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Mon, 09 Apr 2018 00:00:00 EDT 0
<![CDATA[Director of New Product Planning ]]> Our client is a Commercial Oncology organization and is seeking a Director of New Product Planning reporting to the VP Commercial Marketing. The Director of New Product Planning will lead the development of the strategic marketing direction of key assets in the current Oncology pipeline and the basket of upcoming Oral Oncology pipeline assets.

Job Responsibilities:

  • Lead the strategic and tactical aspects of pipeline commercialization for Solid Tumor assets in collaboration with the existing U.S. Oncology Teams, Medical Affairs, Regulatory, Research & Development, Managed Health Care, Forecasting, Finance, Business Development and Licensing & Acquisition, and the Global team (primarily Global Commercial Development and Global Marketing & Commercial Operations).

  • Ensure priorities of the commercial Oncology Franchise are embedded and shape the overall strategies for Asset Teams at various stages of development.

  • Serve as the U.S. Commercial point of contact & subject matter expert on matrix teams like the Global Commercial Teams.

  • Build organizational readiness, knowledge base & expertise, and strategic direction of these pipeline assets in new indications.

  • Develop deep commercial insights on competitive landscape, payer/reimbursement requirements, unmet medical needs, and evolving treatment patterns.

  • Co-lead and participate in market research and insights, financial planning, and strategic planning for these pipeline assets.

  • Contribute to the development of internal and/or external communications pertaining to the Oncology pipeline, as appropriate.

  • Partner with all stakeholders to help inform the design of efficient Marketing and Sales organizations, over time.

  • Develop and oversee budget for assigned initiatives.

  • Develop annual commercial plans for each pipeline asset.

  • Manage consultants/agencies for key projects.

  • Build current and future competitive advantage by understanding & addressing key customers’ needs, and by demonstrating deep understanding of competitors’ strategies.

  • Develop internal and external customer relationships that successfully drive business objectives.

  • Ensure timely guidance to senior management regarding the strategy and key brands.

  • Establish a productive work environment by creating trust and respect within the franchise.

  • Balance business priorities and resources, adapting to the external and internal environment.

  • Position requires excellent communication skills and strong analytical skills to understand scientific and financial data, recognize key issues, establish priorities, and prepare high-level presentations for senior executive staff review.

  • Supervisory/Management Responsibilities – could eventually lead a small team.


Qualifications / Requirements:

  • 12-15 years of experience in the pharmaceutical/biotech industry in progressive commercial leadership roles.

  • Oncology experience required, preferably 5+ years of operational experience at a minimum.

  • Leadership experience in a combination of strategic marketing, pipeline marketing, new product planning, launch planning, R&D portfolio strategy, and/or market research/analytics.

  • Must possess strong scientific and clinical understanding of Oncology.

  • Bachelor’ s degree required, advanced degree preferred.

  • U.S. Commercial experience required with strong matrix skills and cultural sensitivity.

  • Demonstrated ability to influence and manage a complex set of internal and external stakeholders.

  • Strong executive presence and leadership skills.

  • Capable of attracting and developing world-class commercial talent.

  • Strong communication and negotiating skills required.

  • Key Leadership Competencies

  • Builds strong relationships with peers and cross functionally with partners outside of team to enable higher performance.

  • Learns fast, grasps the “ essence”, and can change course quickly when necessary.

  • Raises the bar and is never satisfied with the status quo.

  • Creates a learning environment, open to suggestions, and experimentation for improvement.

  • Embraces the ideas of others, nurtures innovation, and manages innovation to reality.
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Tue, 03 Apr 2018 00:00:00 EDT 0
<![CDATA[Associate Director/Director Regulatory Affairs, CMC]]> Our client is looking for an Associate Director/Director Regulatory Affairs, CMC. They will lead the CMC regulatory strategy and processes for assigned programs to significantly contribute in driving the development of our assets forward.

Job  Responsibilities:
  • Acting as the primary CMC regulatory representative on selected programs to develop CMC regulatory strategies, submissions and compliance activities
  • Managing CMC regulatory activities and timelines
  • Developing the strategy for meetings with regulatory authorities addressing necessary CMC requirements
  • Leading the planning and preparation of the CMC sections of global regulatory submissions
  • Collaborating with the greater CMC teams to provide regulatory guidance
  • Developing and maintaining regulatory knowledge of US, EU and ROW regulations
  • Performing literature searches, preparing special reports and assembling documentation to support project teams
  • Assisting in the development and maintenance of departmental processes, policies, SOPs and associated documents
  • Participating in initiatives aimed at improving internal departmental standards and systems


Qualifications/ Requirements:
  • Minimum of 8 years of experience in a biotech and/or pharmaceutical environment, including 4-5 years of Regulatory CMC experience
  • Minimum requirement of a Bachelor’ s Degree in a scientific discipline or equivalent
  • Experience with biologics program from development through registration
  • Experience in interacting and meeting with regulatory agency personnel on CMC related topics (e.g FDA, EMA etc.)
  • Experience in compiling and reviewing CMC sections of regulatory submissions (INDs, IMPDs, CTAs, BLAs, MAAs, etc.)
  • Knowledge of: drug development; FDA, EMA and ICH CMC guidelines and regulations; current Good Manufacturing Practices (cGMP)
  • You must be a team player that can handle multiple tasks simultaneously in a fast growing company
  • Possess outstanding verbal and written communication skills
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Wed, 21 Mar 2018 00:00:00 EDT 0
<![CDATA[Manager, Medical Information]]> Our client is seeking a Manager, Medical Information who will report to the Associate Director, Medical Information.

Job  Responsibilities:
  • Supports day to day operations of Medical Information Services function
  • Responsible for the Creation and maintenance of MI documents and ensures that information is scientifically accurate, timely, balanced, and meet customers’ needs
  • Manages medical information responses and materials through the internal medical, legal and regulatory review process  
  • Responsible for tracking responses to medical information requests from internal and external customers through the MI Response Center vendor 
  • Responsible for ensuring that the documentation of the MI inquiries and responses accurately and completely comply with relevant Standard Operating Procedure (SOP)/ Work Instruction and regulatory guidelines
  • Monitors adverse events and product quality complaints and processes in accordance with company SOPs
  • Assists in the creation of metric reports on key business processes to monitor Medical Information services
  • Liaise with publications and clinical development groups to develop and maintain timely and relevant product expertise
  • Perform critical analysis and synthesis of internal/external literature related to products and therapeutic areas of focus
  • Exhibits broad knowledge of assigned therapeutic areas, product labelling and regulatory guidance
  • Serves as Medical Affairs liaison to cross-functional groups for the incorporation of current medical/scientific information into departmental documents and processes. 


Qualifications/ Requirements:
  • Advanced clinical and scientific training/experience required equivalent to PharmD, PhD, MD or other advanced degree
  • Minimum of 2 years Medical Information experience with 5+ years in the pharmaceutical/ biotechnology industry
  • Understanding of and adherence to regulatory policies governing scientific interactions with physicians
  • Experience working with vendors on a day-to-day basis
  • Experience with data management and informatics;
  • Excellent written and oral communication skills;
  • Prior industry experience in a post-marketing setting
  • U.S. Launch experience; Orphan, CNS, and / or acute care preferred
  • Ability to quickly understand and communicate all clinical data / publications to support business objectives
  • An outstanding track record of strong communication, presentation, analytic and strategic capabilities
  • This position requires US and international travel, approximately 10 – 25%
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Tue, 20 Mar 2018 00:00:00 EDT 0