Director, Medical Writing

Zenasbio; Waltham (MA); On-site; USD 178,000 - 223,000; Full time

Job summary

An established industry player in biopharmaceuticals is seeking a Director of Medical Writing to lead the development of high-quality regulatory documents. This role offers a unique opportunity to work in a fast-paced environment, contributing to innovative therapies that address significant medical needs. The ideal candidate will have extensive experience in medical writing and project management, ensuring compliance with regulatory standards while guiding a collaborative team. Join a forward-thinking company committed to excellence and innovation in the healthcare sector.

Benefits

Bonuses

Equity

Comprehensive benefits package

Incentives

Qualifications

• Proven track record in Medical Writing with 7+ years of experience.
• Experience leading clinical and regulatory document development.

Responsibilities

• Lead writing strategy and manage document content for projects.
• Collaborate to establish SOPs and quality control checklists.

Skills

Medical Writing

Project Management

Regulatory Compliance

English Grammar

Biostatistics

Education

Bachelor’s degree in a scientific discipline

Tools

Microsoft Office

Veeva Vault

AI Writing Tools

Job description

Zenas BioPharma is a global biopharmaceutical company committed to becoming a leader in the development and commercialization of immune-based therapies for patients worldwide. With clinical development and operations globally, Zenas is advancing a diverse portfolio of potential first- and best-in-class autoimmune therapeutics addressing high unmet medical needs, while meeting the value demands of the global healthcare environment. The company's pipeline continues to grow through successful business development strategies. Our experienced leadership team and network of partners drive operational excellence to deliver transformative therapies that improve lives affected by autoimmune and rare diseases.

We seek top talent who share our commitment to patients and have a proven track record in acquiring, developing, and commercializing products globally. Our colleagues have the opportunity to work in a fast-paced environment and experience success as we aim to become a leader in immunology and autoimmune diseases, embodying our values of Transparency, Relationships, Urgency, Excellence, and Innovation – TRUE Innovation.

Position Summary:

The Director of Medical Writing (MW) will oversee assigned programs and projects, including developing and delivering clinical and scientific data to regulatory agencies, healthcare professionals, and stakeholders. Responsibilities also include contributing to the development and maintenance of SOPs, style guides, and quality control checklists to ensure document and process consistency. The ideal candidate will have a proven track record in Medical Writing, working directly with project teams and external vendors to produce high-quality, submission-ready documents (e.g., INDs, filings, protocols, IBs, CSRs) and publications (abstracts, presentations, journal articles). This role reports to the Executive Director of Medical Writing.

Key Responsibilities:

1. Lead writing strategy, manage document content and timelines, and coordinate relevant stakeholders for assigned projects.
2. Collaborate to establish SOPs, style guides, and quality control checklists to ensure consistency.
3. Advise on document development, ensuring compliance with regulations, ICH guidelines, and SOPs.
4. Author and guide team members in creating clear, concise, submission-ready clinical and regulatory documents.
5. Serve as subject matter expert for data transparency deliverables.
6. Plan strategically, anticipate issues, and recommend process improvements.
7. Perform other medical writing duties as assigned.
8. Promote a collaborative team culture through leadership and example.
9. Adapt quickly to changing strategies when necessary.

Qualifications:

1. Bachelor’s degree in a scientific discipline or related field, or equivalent experience.
2. 7+ years of medical writing experience in pharma, biopharma, or CRO.
3. Strong knowledge of English grammar and AMA style guide.
4. Experience leading clinical and regulatory document development and managing projects.
5. Track record of contributing to successful regulatory filings (IND/CTAs, NDA/BLA/MAA).
6. Knowledge of biologics, clinical research, study design, biostatistics, and medical terminology.
7. Proficiency in Microsoft Office, with experience in Veeva Vault and AI writing tools a plus.
8. Ability to thrive in a fast-paced, collaborative environment with evolving processes.
9. Flexibility to work non-traditional hours across time zones.

Additional Information:

The salary range for this role is $178,400 to $223,000, based on experience, education, and location. Zenas offers a comprehensive total rewards package, including bonuses, equity, benefits, and incentives. We are an equal opportunity employer committed to diversity and inclusion.