The Associate Director/Director Medical Writing will build and manage the staff of medical writers and editors (in house and contract) for various regulatory and clinical documents intended for regulatory submissions. This staff is experienced in medical writing, staff management and has a consistent track record delivering high quality regulatory documents.
In addition to managing the medical writing group, the Assoc Director/Director Medical writing will represent Medical Writing on product teams. Essential skills include the ability to develop clear, concise documents on tight timelines; demonstrated skill in writing from statistical output; an understanding of statistics, the principles of clinical research, the relevant regulations and guidelines, and AMA style; and careful attention to detail.
Key Accountabilities/Core Job Responsibilities:
- Build, manage and supervise staff of medical writers and editors (in house and contract).
- Supervise all aspects of document development: Develop and manage the timeline to support on time document completion, chair key message and review meetings, manage the review and approval process, and work with the publishing group as required to support their work.
- Writing projects include: clinical study reports, investigator’s brochures, clinical summaries and overviews, clinical study protocols and other regulatory-related documents. May also facilitate writing other documents, such as briefing books, manuscripts, meeting abstracts/posters/presentations. The majority of work relates to preparation of NDA and sNDA documents.
- Remain up-to-date on regulatory requirements/guidelines and current industry practices related to clinical regulatory writing.
- Responsible for medical writing templates/standards, SOPs, or other guidelines for regulatory documents.
- Understanding of the principles of clinical research, the regulations and guidelines relevant to clinical regulatory document development, and AMA style
- Demonstrated ability to supervise multiple writing projects on tight timelines, working in multidisciplinary teams and resolving critical path issues in cross-functional team setting
- Demonstrated ability to interpret and present complex clinical data, interpretation of statistical outputs and a good understanding of statistics
- Excellent written and verbal communication skills; excellent problem-solving skills
- In-depth knowledge of Microsoft Office products
Education Requirements (degree, certifications, etc.):
- BA/BA with at least 5 years of relevant writing experience in the pharmaceutical/biotechnology industry, advanced degree and prior work in oncology therapeutics is a strong plus
Pharmacyclics, Inc. - 22 months ago