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.