[Hiring] Senior Director, Medical Writer @Generate Biomedicines
This description is a summary of our understanding of the job description. Click on 'Apply' button to find out more.
Role Description
We are seeking an experienced and highly strategic Senior Director, Medical Writing to lead the development of critical regulatory documents across our pipeline of biologic therapeutics, including:
• Clinical Study Protocols and Amendments
• Investigator’s Brochures (IBs)
• Clinical Study Reports (CSRs)
• Manuscript publications
• Briefing Documents for regulatory meetings (e.g., Type B, EOP2, BTD, ODD)
• Module 2 summaries (2.5, 2.7.1–2.7.4) and other CTD components
Here's how you will contribute:
• Interpret complex nonclinical and clinical data and synthesize them into clear, concise narratives aligned with regulatory standards.
• Serve as the lead medical writer on cross-functional teams, providing scientific and regulatory writing strategy throughout product development.
• Ensure alignment with FDA, EMA, and ICH guidance documents, and oversee document QC, accuracy, and consistency.
• Support inspection readiness by ensuring high-quality documentation and traceability of source content.
• Develop and maintain document templates, style guides, and best practices.
• Manage outsourced medical writing vendors and contractors, ensuring compliance with project timelines, content expectations, and submission standards.
• Participate in regulatory strategy discussions, contributing to the authoring of high-stakes submissions and regulatory responses.
Qualifications
• Minimum 15 years of medical writing experience in the biotechnology or pharmaceutical industry. Consideration for top talent at the Director level with 10-14 years of medical writing experience and an advanced degree.
• Advanced degree in life sciences (PhD, PharmD, or MS) strongly preferred.
• Extensive experience with nonclinical writing, including contributions to nonclinical study reports and nonclinical publications.
• Demonstrated excellence in authoring core clinical documents: protocols, IBs, CSRs, narratives, and clinical summaries.
• Strong knowledge of ICH guidelines and regulatory requirements for global regulatory submissions.
• Excellent writing, editing, and analytical skills with a proven ability to translate complex scientific data into well-structured, regulatory-compliant documents.
• Ability to work independently, manage multiple projects, and meet tight deadlines in a fast-paced environment.
• Experience managing medical writing components of BLA/MAA submissions and coordinating cross-functional inputs.
• Familiarity with eCTD submission standards and document management platforms (e.g., Veeva Vault).
• Experience overseeing contractors or vendor-managed writing teams.
Requirements
• Location: Remote; travel required to Somerville, MA office as business dictates.
Benefits
• Annual bonus eligibility
• Equity compensation
• Competitive benefits package
Compensation
The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, and market dynamics.
Per Year Salary Range: $213,000 — $320,000 USD
Apply Now
Apply Now
Role Description
We are seeking an experienced and highly strategic Senior Director, Medical Writing to lead the development of critical regulatory documents across our pipeline of biologic therapeutics, including:
• Clinical Study Protocols and Amendments
• Investigator’s Brochures (IBs)
• Clinical Study Reports (CSRs)
• Manuscript publications
• Briefing Documents for regulatory meetings (e.g., Type B, EOP2, BTD, ODD)
• Module 2 summaries (2.5, 2.7.1–2.7.4) and other CTD components
Here's how you will contribute:
• Interpret complex nonclinical and clinical data and synthesize them into clear, concise narratives aligned with regulatory standards.
• Serve as the lead medical writer on cross-functional teams, providing scientific and regulatory writing strategy throughout product development.
• Ensure alignment with FDA, EMA, and ICH guidance documents, and oversee document QC, accuracy, and consistency.
• Support inspection readiness by ensuring high-quality documentation and traceability of source content.
• Develop and maintain document templates, style guides, and best practices.
• Manage outsourced medical writing vendors and contractors, ensuring compliance with project timelines, content expectations, and submission standards.
• Participate in regulatory strategy discussions, contributing to the authoring of high-stakes submissions and regulatory responses.
Qualifications
• Minimum 15 years of medical writing experience in the biotechnology or pharmaceutical industry. Consideration for top talent at the Director level with 10-14 years of medical writing experience and an advanced degree.
• Advanced degree in life sciences (PhD, PharmD, or MS) strongly preferred.
• Extensive experience with nonclinical writing, including contributions to nonclinical study reports and nonclinical publications.
• Demonstrated excellence in authoring core clinical documents: protocols, IBs, CSRs, narratives, and clinical summaries.
• Strong knowledge of ICH guidelines and regulatory requirements for global regulatory submissions.
• Excellent writing, editing, and analytical skills with a proven ability to translate complex scientific data into well-structured, regulatory-compliant documents.
• Ability to work independently, manage multiple projects, and meet tight deadlines in a fast-paced environment.
• Experience managing medical writing components of BLA/MAA submissions and coordinating cross-functional inputs.
• Familiarity with eCTD submission standards and document management platforms (e.g., Veeva Vault).
• Experience overseeing contractors or vendor-managed writing teams.
Requirements
• Location: Remote; travel required to Somerville, MA office as business dictates.
Benefits
• Annual bonus eligibility
• Equity compensation
• Competitive benefits package
Compensation
The base salary range provided reflects our current estimate of what we anticipate paying for this position. Your actual base salary will be based on several factors, including job-related skills, experience, internal equity, relevant education or training, and market dynamics.
Per Year Salary Range: $213,000 — $320,000 USD
Apply Now
Apply Now