Director, Medical Writing
B
BiogenBiotechnology, Pharmaceuticals
Remote, USAFull-TimeDirector
Salary$191,000.00-$263,000.00
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Job Details
- Experience
- BSc + 12 years or Advanced degree + 7 years
- Required Skills
- Project Management
Requirements
- BSc with at least 12 years of experience in Medical Writing, or an Advanced degree with at least 7 years of experience.
- Proven experience in a pharmaceutical, biotechnology, or CRO setting.
- Expert knowledge of global regulatory submission requirements (e.g., BLA/NDA, MAA).
- Familiarity with eCTD format and document relationships.
- Expertise in ICH, FDA, and EMA guidelines and public disclosure requirements.
- Proven experience authoring documents and leading teams through the authoring process.
- Strong project management skills with the ability to prioritize multiple projects.
- SME in MS Word.
- Proficiency in document management systems such as Veeva or SharePoint.
- Collaborative experience working in a matrix environment.
Responsibilities
- Prepare clinical and regulatory document packages including protocols, amendments, CSRs, IBs, INDs/CTAs, and submissions.
- Lead the planning, development, and delivery of documents according to ICH guidelines, company SOPs, and regulatory requirements.
- Collaborate with cross-functional SMEs in Clinical Development, Regulatory Affairs, Biostatistics, Pharmacovigilance, and Clinical Operations.
- Review statistical analysis plans and clinical data reports incorporated in CSRs and IBs.
- Manage and provide oversight of in-house and contractor/vendor medical writers, providing mentorship and career development.
- Represent Medical Writing in meetings with governance committees, regulatory agencies, and external partners.
- Develop and integrate messaging and medical writing strategy across therapeutic areas.
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