Associate Director, Medical Writing - Perm - Raleigh, Remote
Proclinical is seeking a dedicated and experienced Associate Director for Medical Writing. This role is pivotal in creating and managing high-quality regulatory and clinical documents.
Primary Responsibilities :
The successful candidate will work closely with cross-functional teams to ensure documents are scientifically accurate and regulatory compliant.
Skills & Requirements :
- B.S. / B.A. degree required; advanced degree preferred.
- Relevant medical writing experience in the pharmaceutical industry, with expertise in ophthalmology or rare diseases.
- Strong understanding of drug development processes.
- Leadership and mentorship experience to support early-career writers.
- Experience working with cross-functional teams and managing external contractors or writers.
- In-depth knowledge of FDA regulations, ICH guidelines, and clinical research concepts.
- Ability to work independently, manage multiple projects, and meet deadlines in a fast-paced environment.
- Excellent verbal and written communication skills.
The Associate Director, Medical Writing's responsibilities will be :
- Author and coordinate clinical and regulatory documents with input from development team members, ensuring alignment across projects.
- Lead the writing and project management of clinical regulatory documents.
- Maintain consistency in style, scientific content, and messaging across therapeutic area documents.
- Provide strategic input from a medical writing perspective on regulatory submissions.
- Ensure compliance with ICH and other relevant regulatory guidelines.
- Actively participate in cross-functional meetings and provide insights into medical writing deliverables.
- Review clinical and regulatory documents to ensure quality and consistency across programs.
- Lead team review meetings and track document progress throughout project lifecycles.
- Oversee document preparation and status reporting, ensuring timely and high-quality delivery.
- Support continuous improvement of medical writing processes within the organization.
- Provide guidance and mentorship to junior writers.
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