Senior Manager, Medical Writing

Apogee Therapeutics

Senior Medical Writer responsible for preparing and editing clinical documentation in a biotech company. Collaborating with teams to ensure high-quality, regulatory-compliant submissions.

Posted 5/8/2026full-timeRemote • 🇺🇸 United StatesSenior💰 $160,000 - $180,000 per yearWebsite

About the role

Key responsibilities & impact

Collaborates with cross-functional teams to prepare, review, and edit high-quality, scientifically accurate, and submission-ready documents including, but not limited to: protocols, investigator’s brochures, clinical study reports, briefing documents, Module 2 summary documents, and other clinical and regulatory documents.
Communicates deliverables needed, writing process, and timelines to team members, and holds team members accountable to agreed-upon document milestones.
Negotiates with functional areas regarding deliverables and timelines to meet conflicting demands, removing barriers and using creativity to ensure teams achieve document-related project goals
Ensures compliance with relevant regulatory guidelines, industry best practices, and ethical standards in medical writing and communication.
Maintains document templates, style guides, and best practices to ensure consistency and quality in written materials.
Oversees the planning, coordination, and execution of medical writing projects by external vendors and consultants to ensure milestones are met and resources are allocated efficiently.
Leverages AI-enabled tools to enhance efficiency and quality of medical writing deliverables while maintaining scientific rigor and regulatory compliance.
Helps define and implement best practices for the responsible use of AI within medical writing workflows.
Provides guidance to less experienced medical writers and external vendors.

Requirements

What you’ll need

Bachelors in science (advanced degree is a plus), with 8+ years of experience in medical writing in the pharmaceutical or biotech industry.
Ability to understand, critically analyze, and interpret data and summarize complex results in an unambiguous, concise, and scientifically accurate manner
Well-developed interpersonal and communication skills, with experience interacting with and influencing people, and building strong, positive relationships
Proven organizational skills and the ability and flexibility to work across a variety of teams and manage multiple competing priorities in a fast-paced startup environment
Experience with independently authoring a range of scientific documents and the ability to oversee such authoring done by third parties
Detail-oriented, with exceptional organizational and project management skills
Proficient in using scientific writing tools (eg, Microsoft Office suite, document management systems, reference management software) and ability to quickly learn new software applications.

Benefits

Comp & perks

A great culture, grounded in our C.O.R.E. values: Caring, Original, Resilient and Egoless
Opportunity to work in a fast-paced, highly dynamic environment where you help shape the culture and company, wear multiple hats, and learn quickly
Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits
We provide competitive time off, including three weeks PTO, two one-week company-wide shutdowns a year and dedicated paid sick leave
Commitment to growing you professionally and providing access to resources to further your development
Apogee offers regular all team, in-person meetings to build relationships and problem solve

ATS Keywords

✓ Tailor your resume

Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools

medical writingscientific writingdata analysisproject managementregulatory compliancedocument authoringeditingprotocol developmentclinical study reportsbriefing documents

Soft Skills

interpersonal skillscommunication skillsorganizational skillsflexibilityteam collaborationrelationship buildingcreativityaccountabilityguidancedetail-oriented