Job Description

Job Title: Medical Writer III (Associate Director Level)

Location: Remote

Job Type: Full-Time, Contract

Industry: Pharmaceutical / Biotechnology

Position Summary:

We are seeking a highly skilled Medical Writer III at the Associate Director level to join a dynamic team supporting innovative drug development programs. This remote role is ideal for an experienced medical writing professional with a strong background in Phase 1 pharmacology protocols and a minimum of 3 years in the pharmaceutical industry .

You will lead major medical writing initiatives and prepare a variety of high-impact scientific and regulatory documents across therapeutic areas, ensuring clarity, compliance, and strategic alignment.

Key Responsibilities:

• Lead the development of clinical and regulatory documents such as protocols, clinical study reports (CSRs), investigator brochures (IBs), safety summaries, pharmacokinetic reports, and submission-ready materials for INDs/NDAs/BLAs
• Interpret complex clinical and statistical data and convert it into scientifically accurate and well-organized narrative content
• Collaborate with cross-functional teams including Clinical Development, Regulatory Affairs, Medical Affairs, and Biostatistics
• Review and coordinate the work of freelance or contract medical writers as needed
• Support communication strategies for regulatory submissions
• Ensure adherence to relevant regulatory guidelines (e.g., FDA, ICH) and internal documentation standards
• Contribute to process improvements within the medical writing function

Qualifications:

• Education:
• PhD in Life Sciences or PharmD with 5+ years of experience
• MS in Life Sciences with 7+ years of experience will also be considered
• Experience:
• Minimum 3 years of industry experience in medical writing
• Strong knowledge of early-phase (Phase 1) clinical trials, particularly pharmacology protocols
• Familiarity with CNS/neuroscience therapeutics is a plus
• Experience preparing regulatory submissions (IND/NDA/BLA)
• Certification through AMWA or equivalent (preferred)
• Skills:
• Excellent writing, editing, and communication skills
• Ability to work independently and manage multiple projects
• Proficiency in interpreting clinical data and creating submission-ready documents
• Strong understanding of regulatory writing standards and electronic document management systems

Additional Details:

• Fully remote position
• Occasional overnight travel may be required
• Must be able to lift up to 20 lbs and function in a standard or remote office environment

Apply today to make an impact in the advancement of new therapies and help shape the future of drug development.

Benefits : Use this link bit.ly/4cGUQSh to learn more about benefits available to Eastridge’s temporary employees. From time to time Eastridge’s clients may offer additional benefits to Eastridge employees while on assignment. Information about those benefits will be communicated when applicable.

Eastridge Workforce Solutions is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion, age, sex, national origin, disability status, genetics, protected veteran status, sexual orientation, gender identity or expression, or any other characteristic protected by federal, state or local laws. We celebrate diversity and are committed to creating an inclusive environment for all employees. Please note that Eastridge is unable to provide visa sponsorship to applicants.

Certain clients require Eastridge to perform background checks and Eastridge will consider qualified applicants with criminal histories in a manner consistent with any applicable federal, state, or local law regarding criminal backgrounds, including but not limited to the Los Angeles Fair Chance Initiative for Hiring and the San Francisco Fair Chance Ordinance.

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