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Associate Director, Medical Writing

Cambridge, MA

Posted: 06/05/2019 Employment Type: Direct Hire Job Category: Clinical: Medical Writing Job Number: 2343

Our client is searching for a creative, resourceful, integrative thinker for an important role as an Associate Director, Medical Writing. The person in this role is responsible for planning and preparing clinical and regulatory documents (protocol, CSR, IB, clinical sections clinical trial and marketing authorization applications, periodic annual reports, etc.) according to company guidelines and international governmental regulations. The Associate Director, Medical Writing is responsible for presenting clinical data objectively in a clear, concise format, and also for organizing and managing the reviews for these documents. This position will have a role in the leadership of the department, and in overseeing/managing medical writing vendors, contract staff, and/or junior medical writers. The Associate Director, Medical Writing will function under the guidance and direction of the head of the medical writing department. The successful candidate will be an independent, proactive, experienced medical writer with experience working in a clinical development environment.

RESPONSIBILITIES INCLUDE:
  • Works with colleagues from various functional areas in Clinical Development, Clinical Operations, Medical Science, Medical Affairs, Regulatory, and Program Management in planning and preparation of high quality clinical and regulatory documents, including protocols, study reports, investigator brochures, etc., according to company and agency guidelines in order to support drug development under strict timelines.
  • Independently writes as well as oversees and manages the work of other medical writers. This includes training and mentoring in addition to participation in assessing workload and managing work assignments.
  • Contributes to and/or manages the production of relevant documentation for regulatory submissions.
  • Proactively and independently works to ensure continuous improvement, and high standards for quality and productiveness; provide suggestions based on area of expertise and prior experience.
  • Leads the Medical Writing team in designing and maintaining templates/standards for protocols/reports in accordance with ICH guidelines and medical writing best practices.
  • Provides leadership in area of expertise.
  • Has a working knowledge of the company’ s financial goals and metrics.
  • Collaborates with department management on the departmental budget and planning; authorize payment of work on projects and accountable to ensure successful completion and payment of work.
  • Suggests direction and strategic ideas within area of expertise.
  • Provides managerial leadership in area of expertise.

REQUIREMENTS / QUALIFICATIONS:
  • MS or equivalent in a biological science with 7+ (or BS with 10+) years of medical writing experience in the pharmaceutical industry; specific experience in neuroscience, psychiatry, or related field is ideal.
  • Must thrive working in a fast-paced, innovative environment while remaining flexible, proactive, resourceful and efficient.
  • Excellent interpersonal skills, ability to develop important relationships with key stakeholders, good conflict management and negotiation skills, ability to analyze complex issues to develop relevant and realistic plans, programs and recommendations.
  • Demonstrated ability to translate strategy into action; excellent analytical skills and an ability to communicate complex issues in a simple way and to orchestrate plans to resolve issues and mitigate risks.
  • Expertise in drug development, clinical research, medical terminology, study design, and the regulatory requirements for clinical and regulatory documents.
  • Keen understanding of the requirements for preparation of key clinical and regulatory documents.
  • 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.

Lisa Madden
EVP, Clinical Staffing

Lisa is an inspiring leader and mentor, driven by an inherent desire to help others and make a difference. An advocate for growth and professional development, Lisa brings 18 years of recruiting and business development experience to The Steely Group, and as Executive Vice President of Clinical Staffing, she oversees the direction and strategy of the Steely recruiting team.

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