[ref. y29068701] Associate Director Medical Writing

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.

If you are having difficulty in applying or if you have any questions, please contact Merna Hermiz at m.hermiz@proclinical.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.