Senior Manager, Medical Writing

Summary

Join Apogee Therapeutics, a fast-growing biotechnology company, as a Medical Writer. You will play a key role in preparing and reviewing clinical and regulatory documents, collaborating with cross-functional teams. This position requires strong medical writing expertise, experience in the pharmaceutical or biotech industry, and excellent communication skills. You will ensure compliance with regulatory guidelines and contribute to maintaining document templates and style guides. Apogee offers a competitive compensation and benefits package, including a great company culture, flexible PTO, and professional development opportunities. The ideal candidate possesses a Bachelor's degree in science (advanced degree preferred) and 8+ years of relevant experience.

Requirements

• 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

Responsibilities

• 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
• Provides guidance to less experienced medical writers and external vendors

Benefits

• A great culture, grounded in our C.O.R.E. values: C aring, O riginal, R esilient 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
• Flexible PTO
• Two, one-week company-wide shutdowns each year
• 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