For our client, we are seeking a Director, Medical Writing WCH to join the team of a leader in the Pharmaceuticals & Biotech space.

This role will lead the development and delivery of high-quality clinical and regulatory documents that support key submissions across the product lifecycle. You will partner closely with cross-functional subject matter experts to ensure scientific accuracy, regulatory alignment, and timely execution in a fast-paced environment. The position also provides oversight, mentorship, and process leadership to strengthen the medical writing function.

Location: Remote - US based candidates only, no visa sponsorship available

Compensation: $191,000 – $263,000 annually

Responsibilities

• Prepare clinical and regulatory documents, including protocols and submission-related materials
• Lead and oversee document development and delivery in accordance with applicable guidelines
• Review content for scientific accuracy and consistency
• Collaborate with cross-functional subject matter experts
• Manage document development timelines and submission activities
• Provide oversight and mentoring to junior medical writers
• Lead departmental initiatives as needed

Qualifications

• Minimum of a BSc plus 12 years of experience, or an advanced degree plus 7 years of experience in medical writing
• Experience with global regulatory submissions, including BLA/NDA and MAA filings
• Familiarity with eCTD format and document interrelationships
• Strong knowledge of ICH, FDA, and EMA guidelines
• Proven experience authoring documents and leading teams
• Strong project management skills in a fast-paced environment
• Advanced proficiency in MS Word and document management systems such as Veeva and SharePoint

Benefits

• Comprehensive medical, dental, vision, and life insurance
• Fitness and wellness programs, including reimbursement
• Minimum of 15 days of paid vacation plus an additional year-end shutdown
• Up to 12 company-paid holidays and 3 personal significance days
• Paid maternity and parental leave
• 401(k) program with company match
• Employee stock purchase plan
• Tuition reimbursement up to $10,000 per year

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