Director of Medical Writing
Proclinical is currently recruiting for a Director of Medical Writing with a leading biotechnology company located in Seattle, WA. As the Medical Writing Director, you will report to the Head of Regulatory Affairs and be responsible for working cross-functionally with internal team members and stakeholders to develop, implement, and maintain a standardized document development process for nonclinical and clinical documents, regulatory submissions to US and other global health authorities, presentations, posters, and publications in peer reviewed journals.
- Responsible for authoring and revising clinical and regulatory documents for submission to global Health Authorities, and to support other clinical communication efforts including abstracts and presentations for medical congress meetings and manuscripts for publication in peer-reviewed journals.
- Lead establishment of Medical Writing standards and best practices at a rapidly growing biotechnology company and serve as the Medical Writing lead on the regulatory, clinical development team(s), and publication planning team.
- Position Summary: The Director, Medical Writing
- Responsibilities: Prepare Investigational New Drug (IND) applications, amendments, annual reports, New Drug Applications (NDA) and/or Marketing Authorization Applications (MAA), and other documents to support global product development.
- Lead the development and authoring of nonclinical and clinical regulatory documents including; clinical protocols, clinical study reports, investigator brochures, safety updates, annual reports, scientific briefing documents, investigator brochures and nonclinical and clinical summaries in support of regulatory filings in collaboration with clinical study teams.
- Develop and manage timelines and resources for clinical and regulatory documents.
- Collaborate cross-functionally to drive projects to completion.
- Lead publication planning team in the strategic publication planning process and implementation of publication plans, including working with author groups to develop and author manuscripts, abstracts, and presentations for scientific congresses.
- Lead the development and authoring of abstracts and slides or posters presenting clinical study data at medical congresses and the development of primary manuscripts for publication in peer-reviewed journals including direct collaboration with internal and external authors.
- Coordinate/lead the activities of multiple contributors to medical writing projects/submissions.
- Organize, conduct, and lead cross-functional document development meetings.
- May oversee clinical library/information systems (Endnote).
- Interact closely with internal and external stakeholders in the development of statistical analysis plans and design of statistical outputs demonstrating advanced problem-solving ability.
- Routinely engage clinical development and biostatistics to gain comprehensive understanding of compound and the design, objectives, and results of clinical trials to enable accurate and effective communication to varied audiences.
- Represent medical writing on multiple study/project teams and contributes to program strategy, through collaborative engagement with personnel from other clinical disciplines, regulatory affairs, and scientific departments.
Skills and Requirements:
- Bachelor's degree (or equivalent) in a relevant field, with advanced degree preferred, and 10+ years of biotech/pharmaceutical experience, including 3 to 5 years direct medical writing experience, an extensive portion supporting oncology and/or immuno-oncology programs.
- Experience in oncology and/or inflammatory disease drug development strongly preferred.
- Minimum of 3 years of successful management experience, including experience mentoring and managing the work of other medical writing and contract staff.
- Expertise in preparing clinical regulatory documents and scientific publications is crucialExcellent written and verbal communication skills essential.
- Proven ability to effectively collaborate with internal team and external collaborators, including ability to influence and reach compromises cross functionally to produce a quality document.
- Graduate in medicine along with previous clinical
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If you are having difficulty in applying or if you have any questions, please contact George Watson at (+1) 929-223-4835 or email@example.com.
Proclinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.
Proclinical Staffing is an equal opportunity employer.