Job description

Senior Manager, Medical Writing (Contractor)

Position Summary
A biopharmaceutical company is seeking a highly motivated and well-organized Principal or Senior Manager of Medical Writing to develop clinical and regulatory documents in collaboration with internal and external stakeholders. This individual will apply critical thinking, principles of scientific writing, data interpretation, and expertise in the regulatory content life cycle to deliver high-quality documentation supporting ongoing clinical programs.

Key Responsibilities

Lead the preparation of clinical and regulatory documents (e.g., protocols, investigator brochures [IBs], safety updates, clinical study reports, IND/NDA/MAA CTD submission documents, briefing documents, and responses to regulatory authority questions) in alignment with global and regional regulatory guidelines and company/partner SOPs.
Partner with functional leads to plan content, create timelines, and drive development of assigned documents.
Ensure organization, clarity, scientific accuracy, formatting, and consistency across documents within a program or clinical dossier.
Lead document adjudication meetings and resolve issues with cross-functional contributors.
Manage the review and approval process, including coordination with external partners.
Build strong, collaborative relationships across geographically and culturally diverse teams.

Requirements

Bachelor’s degree in life sciences; advanced degree (MS/PhD) strongly preferred.
Minimum 8 years of direct medical writing experience in the biopharmaceutical industry or related CROs, including at least 3 years in oncology drug development.
Demonstrated ability to independently produce clear, high-quality clinical and regulatory documents across global submissions.
Hands-on experience with protocols, DSURs, IBs, and IND/NDA/MAA CTD submission documents.
Strong project management and facilitation skills, with the ability to lead complex projects in a fast-paced matrix environment.
Proven ability to influence without authority and foster effective collaboration.
Demonstrated adaptability to shifting priorities and evolving project needs.
Excellent written and verbal communication skills, with the ability to present ideas and data to senior stakeholders.
Familiarity with tools and approaches to expedite document preparation (e.g., review platforms, automation).
Solid technical, statistical, and computer skills with the ability to interpret complex clinical data.