Director, Medical Writer chez Generate Biomedicines

About Generate:Biomedicines

Generate:Biomedicines is a new kind of therapeutics company – existing at the intersection of machine learning, biological engineering, and medicine – pioneering Generative Biology™ to create breakthrough medicines where novel therapeutics are computationally generated, instead of being discovered. The Company has built a machine learning-powered biomedicines platform with the potential to generate new drugs across a wide range of biologic modalities. This platform represents a potentially fundamental shift in what is possible in the field of biotherapeutic development.

We pursue this audacious vision because we believe in the unique and revolutionary power of generative biology to radically transform the lives of billions, with an outsized opportunity for patients in need. We are seeking collaborative, relentless problem solvers that share our passion for impact to join us!

Generate:Biomedicines was founded in 2018 by Flagship Pioneering and has received nearly $700 million in funding, providing the resources to rapidly scale the organization. The Company has offices in Somerville and Andover, Massachusetts with 300+ employees.

The Role:

We are seeking an experienced Director, Medical Writing to support the development of critical regulatory documents across our pipeline of biologic therapeutics, including the development of documents such as clinical protocols, Investigator’s Brochures, nonclinical overviews and written summaries, clinical study reports, and nonclinical study reports. The role will also oversee the work of external medical writing contractors and vendors to ensure high-quality, timely, and compliant deliverables. The Director will serve as a key partner to Clinical Development, Regulatory Affairs, Clinical Operations, Biometrics, and Nonclinical teams, helping to ensure alignment of scientific narratives across regulatory and clinical documentation.

Here's how you will contribute:

• · Lead the development and authorship of high-impact regulatory and clinical documents including:

            o Clinical Study Protocols and Amendments

            o Investigator’s Brochures (IBs)

            o Clinical Study Reports (CSRs)

            o Manuscript publications

            o Briefing Documents for regulatory meetings (e.g., Type B, EOP2, BTD, ODD)

            o Module 2 summaries (2.5, 2.7.1–2.7.4) and other CTD components

• · 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 relevant to medical writing.
• · 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.

The Ideal Candidate will have:

• · Minimum 10 years of medical writing experience in the biotechnology or pharmaceutical industry, or an equivalent combination of industry and relevant academic/technical writing experience.
• · 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

Generate:Biomedicines is committed to equal employment opportunity regardless of race, color, ancestry, religion, sex, national origin, sexual orientation, age, citizenship, marital status, disability, gender identity or Veteran status.

Recruitment & Staffing Agencies: Generate:Biomedicines does not accept unsolicited resumes from any source other than candidates. The submission of unsolicited resumes by recruitment or staffing agencies to Generate:Biomedicines or its employees is strictly prohibited unless contacted directly by the Company’s internal Talent Acquisition team. Any resume submitted by an agency in the absence of a signed agreement will automatically become the property of Generate:Biomedicines and the Company will not owe any referral or other fees with respect thereto.

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