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The Steely Group
http://www.thesteelygroup.com
http://www.thesteelygroup.com
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As part of Medical Affairs and reporting to the Sr. Director, Medical Affairs, the Sr. REMS Specialist plans, implements, and executes projects related to the development and management of a commercially-ready risk management program in accordance with company SOPs, FDA, & ICH guidelines and regulations. This position is responsible for administering the company’s REMS program and day-to-day management of the key risk management vendors.
This position plays a pivotal role in managing timelines and deliverables for key risk management milestones for the company. The individual in this role will effectively apply project management-related support to teams and team leaders to meet overall corporate objectives in maintaining a compliant REMS program. In addition, this individual will oversee and execute operational aspects of assigned special projects. This position works with all levels of staff and outside contacts in a professional manner.
RESPONSIBILITIES:
REMS Assessment Report
REMS Operations
Regulatory Support
Miscellaneous
QUALIFICATIONS:
Sr. REMS Specialist
Posted: 09/05/2024
2024-09-05
2024-10-12
Employment Type:
Direct Hire
Job Category: Regulatory
Job Number: 3959
Job Description
As part of Medical Affairs and reporting to the Sr. Director, Medical Affairs, the Sr. REMS Specialist plans, implements, and executes projects related to the development and management of a commercially-ready risk management program in accordance with company SOPs, FDA, & ICH guidelines and regulations. This position is responsible for administering the company’s REMS program and day-to-day management of the key risk management vendors.
This position plays a pivotal role in managing timelines and deliverables for key risk management milestones for the company. The individual in this role will effectively apply project management-related support to teams and team leaders to meet overall corporate objectives in maintaining a compliant REMS program. In addition, this individual will oversee and execute operational aspects of assigned special projects. This position works with all levels of staff and outside contacts in a professional manner.
RESPONSIBILITIES:
REMS Assessment Report
- Generate REMS assessment report, including creating new templates based on most recent FDA feedback and any REMS reporting requirements, collecting and analyzing data, building tables, summarizing results
- Develop and manage project plans and timelines by effectively communicating and addressing potential issues/questions with key stakeholders
- Meet with third-party vendors to review requirements
REMS Operations
- Create and/or revise modified REMS documentation for FDA submission in required formats using Word or Adobe as necessary
- Anticipate REMS requirements or FDA expectations to drive content for REMS, regulatory documents, or internal documents
- Support development of business rules for pharmacy enrollment or decertifications
- Create content for stakeholder communications and training materials for vendors and partners
- Develop Pharmacy Audit Plan and audit questionnaire
- Participate in REMS operations vendor selection; create comparison/budget variances spreadsheet for decision-making
Regulatory Support
- Prepare REMS documents for submission in required formats
- Create content and responses to FDA requests in format required by Regulatory Affairs
- Create comparison and combine revisions to PI and MedGuide
- Participate in FDA on-site audit; prepare follow-up information as requested by FDA
- Circulate documentation through Quality Assurance; address questions; track document control numbers
Miscellaneous
- Develop REMS database process flow
- Create miscellaneous slide presentations for Medical Affairs
- Other duties as assigned
QUALIFICATIONS:
- B.S. or higher in Biological/Medical field, Nursing or Pharmacy or related scientific discipline or comparable field of study from an accredited college or university
- The candidate will have a minimum of 3 years of risk management experience, with 5 years of project management responsibilities which routinely required influencing and directing in a matrixed environment
- Minimum of 3 years’ experience with and working knowledge of the risk management, REMS and the regulatory process are essential
- Excellent verbal and written communication skills with the ability to interface effectively with senior management, interdisciplinary project teams, and external vendors
- Must be proficient MS Office (Word, Excel, PowerPoint, Outlook) Must be proficient with Adobe, PDF document management, and version tracking and control
- Must be detail oriented