Job Description
Position Summary:
We are seeking an experienced and highly motivated Associate Director, Medical Writing to join our Regulatory/Clinical Development team. This leadership role is responsible for the strategic planning, preparation, and delivery of high-quality clinical and regulatory documents in support of global drug development programs. The ideal candidate will have deep experience in authoring and managing a wide range of regulatory and clinical documents, including clinical study protocols, clinical study reports (CSRs), Investigator’s Brochures (IBs), Development Safety Update Reports (DSURs), and US regulatory submissions (e.g., INDs, FDA meeting packages).
Key Responsibilities:
- Lead the planning, development, and delivery of clinical and regulatory documents in accordance with ICH guidelines, company SOPs, templates, and regulatory requirements.
- Author or oversee the writing of key documents including:
- Clinical Study Protocols and Amendments
- Clinical Study Reports (CSRs)
- Investigator’s Brochures (IBs)
- Development Safety Update Reports (DSURs)
- US IND modules (e.g., General Investigation Plan (GIP), Module 2, and other relevant sections)
- FDA briefing documents and meeting packages
- Ensure documents are scientifically accurate, consistent, and aligned with regulatory strategy and messaging.
- Collaborate cross-functionally with Clinical Development, Regulatory Affairs, Biostatistics, Pharmacovigilance, and other departments to gather necessary information and align timelines.
- Provide strategic input to project teams on content, structure, and presentation of documents.
- Manage and mentor medical writers (in-house and/or contractors), ensuring high-quality deliverables and professional development.
- Support the development and maintenance of SOPs, templates, and style guides for medical writing practices.
- Participate in regulatory submission planning and contribute to project timelines.
- Assist in vendor selection and management for outsourced writing projects, ensuring quality and on-time delivery.
Qualifications:
- Advanced degree in life sciences (PhD, PharmD, or MS preferred).
- Minimum of 8 years of experience in medical writing within the pharmaceutical, biotechnology, or CRO industry.
- Proven experience authoring the following documents is required:
- Clinical study protocols and CSRs
- Investigator’s Brochures (IBs)
- DSURs
- IND submissions and FDA briefing documents
- Solid understanding of global regulatory requirements (FDA, ICH, EMA).
- Strong project management skills with the ability to prioritize and manage multiple projects in a fast-paced environment.
- Excellent written and verbal communication skills.
- Proficiency in MS Word and document management systems; experience with electronic submission tools a plus.
- Ability to work independently as well as part of cross-functional teams.
- Experience mentoring or managing junior writers or external vendors preferred.
Preferred Qualifications:
- Experience with global regulatory submissions (e.g., IND, CTA, NDA, MAA).
- Familiarity with electronic Common Technical Document (eCTD) format.
- Prior experience in degenerative diseases, rare diseases, or other therapeutic areas relevant to the company’s pipeline.