Job Description
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Description
The Manager of Medical Writing will oversee and lead the development of high-quality scientific documents, including clinical study reports, regulatory submission documents, publications, and other medical communications. This role requires leadership, strategic oversight, and hands-on writing skills. The ideal candidate will collaborate with cross-functional teams, including clinical, regulatory, and medical affairs teams, to ensure the delivery of accurate, clear, and well-structured documents that meet industry standards and regulatory requirements.
- Requirements
- Leadership & Team Management:
- Lead a team of medical writers, providing mentorship, training, and career development opportunities.
- Assign tasks, set priorities, and manage timelines to ensure timely and high-quality document delivery.
- Foster a collaborative and supportive environment within the team.
- Medical Writing Oversight:
- Develop and oversee the preparation of clinical study reports (CSRs), clinical study protocols, investigator brochures, regulatory submission documents (e.g., INDs, NDAs), and other scientific/medical documents.
- Ensure the accuracy, clarity, and compliance of all documents with internal guidelines, industry standards, and regulatory requirements.
- Review and edit documents for consistency, style, and adherence to medical writing best practices.
- Cross-Functional Collaboration:
- Collaborate with clinical, regulatory, biostatistics, and other functional teams to ensure seamless development of medical writing deliverables.
- Coordinate document preparation, review, and approval processes with internal stakeholders and external partners, such as contract research organizations (CROs).
- Regulatory & Publication Support:
- Support the preparation of regulatory submission documents and assist in the response to regulatory agency inquiries.
- Contribute to the preparation of scientific publications, abstracts, posters, and presentations for medical meetings.
- Process Improvement & Compliance:
- Implement and maintain efficient medical writing processes and tools to improve the quality and efficiency of document preparation.
- Ensure that all writing adheres to current guidelines, including ICH E6, ICH E3, GxP, and other relevant regulatory requirements.
- Quality Control:
- Provide detailed reviews and edits for accuracy, scientific content, grammar, style, and formatting.
- Ensure consistent and high-quality medical writing across all deliverables.
- Training & Development:
- Provide training and development opportunities for junior writers, improving their skills in clinical and regulatory writing.
- Stay updated on current industry trends and regulations to ensure the team is aligned with best practices in medical writing.
- Qualifications
- Education:
- Advanced degree (PhD, MD, PharmD, MS, or equivalent) in a scientific discipline (e.g., life sciences, pharmacology, biostatistics).
- Experience:
- Minimum of 5-7 years of medical writing experience, with at least 2-3 years in a leadership or managerial role.
- Experience in clinical research, regulatory submissions, or biopharmaceutical industry required.
- Proven experience with clinical trial reports, regulatory documents (e.g., IND, NDA), publications, and other medical communications.
- Skills:
- Strong knowledge of medical writing standards and regulatory requirements.
- Excellent writing, editing, and proofreading skills, with the ability to communicate complex scientific concepts clearly and concisely.
- Strong project management skills, with the ability to manage multiple projects and meet tight deadlines.
- Ability to collaborate effectively with cross-functional teams and external partners.
- High attention to detail and a strong commitment to quality.
- Certifications:
- Medical Writing Certification (e.g., from the American Medical Writers Association, or similar) is a plus but not required.
- Additional Skills
- Familiarity with regulatory guidelines (e.g., ICH, FDA, EMA) and industry standards (e.g., GxP).
- Proficiency with medical writing tools (e.g., EndNote, Reference Manager, Microsoft Office Suite, Adobe Acrobat).
- Strong interpersonal and communication skills, with the ability to lead and mentor a team.
Salary Description
$140,000 - $160,000 per year
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