Medical Writer Senior Director

Job Title: Medical Writer (Senior Director)
Company: Biopharma
Location: Boston, MA

Brio Resource Group is a Life Sciences Executive Search Firm committed to providing rare talent on an exclusive search basis to the Biopharma, Pharma, Device, and CRO industries. We work on behalf of organizations that value true talent acquisition partners and specialize in supporting emerging Biopharma companies offering life-changing therapies. Our many years of experience, subject matter expertise, comprehensive search process, and genuine passion to deliver rare talent defines Brio.

Position Overview:
We’ve partnered with a rapidly growing biopharma company seeking an experienced Medical Writer to join their team. This position will be responsible for developing regulatory documents in support of the company’s development programs. The Medical Writer will play a key role in preparing high-quality, accurate, and concise regulatory submissions and documents for clinical and nonclinical development, including IND, NDA, and other key regulatory submissions.

Opportunity Highlights:

  • Plan, prepare, write, edit, and finalize non-clinical, clinical, and regulatory documents such as INDs, NDAs, CTAs, clinical protocols, clinical study reports, and briefing books

  • Assist in the development and implementation of strategies for preparing documents for regulatory health authority submissions

  • Lead cross-functional teams to ensure accurate and timely completion of regulatory documentation

  • Ensure compliance with SOPs, GCP, ICH, and other regulatory standards

  • Perform quality control reviews of medical writing documents

  • Collaborate with internal teams, including clinical research, regulatory, safety, and biostatistics, to ensure the accuracy and quality of submission materials

Position Requirements:

  • 5+ years of Medical Writing experience in a CRO or biopharmaceutical industry

  • BS in life sciences (Advanced degree preferred)

  • Strong interpersonal skills and ability to work both independently and as part of a team

  • Deep understanding of the clinical drug development process and regulatory guidance

  • Proficiency in Microsoft Word, Adobe Acrobat, Microsoft PowerPoint, and other standard software used for writing regulatory documents

  • Exceptional attention to detail with a focus on accuracy and specificity

  • Experience in medical writing for CNS regulatory filings is a strong plus

  • Ability to manage multiple assignments simultaneously and meet deadlines in a fast-paced environment

We welcome the opportunity to provide a full job description upon resume review.