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Senior Manager, Medical Writing
Remote
About Apogee Therapeutics
Founded in 2022, Apogee Therapeutics, Inc. (Ticker: APGE) is a well-funded, Nasdaq listed company that offers the opportunity to work in a fast-paced, highly dynamic environment. At Apogee, you can actively contribute to shaping the company culture, take on various roles and responsibilities, and grow professionally.
Apogee Therapeutics, Inc. is a biotechnology company seeking to develop differentiated biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease and other inflammatory and immunology indications with high unmet need. Our antibody programs are designed to potentially overcome limitations of existing therapies by targeting well-established mechanisms of action and incorporating advanced antibody engineering to optimize half-life and other properties. We seek to reshape the current standard of care for inflammatory and immune diseases because we believe people living with these diseases deserve the best possible treatment, and we refuse to stop at “good enough.”
We are a fast-paced company committed to building an exceptional company culture, founded on our C.O.R.E. values: Caring, Original, Resilient and Egoless.
If this sounds like you, keep reading!
Role Summary
We are seeking an experienced and motivated medical writer who is responsible for providing clinical and regulatory document support and advanced medical writing expertise to cross-functional teams, ensuring the successful and timely preparation of high-quality documents. This individual will also participate in the development and maintenance of document templates, style guides, and standard operating procedures to ensure consistency and quality across documents and will represent Medical Writing at various team meetings. This position reports to the Executive Director, Medical Writing and Regulatory Execution.
Key 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.
Ideal Candidate
- 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.
The anticipated salary range for candidates for this role will be $150,000 - $170,000 per year. The final salary offered will depend on several factors, which may include, but is not limited to relevant years of experience, educational background, and geography.
What We Offer
- 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
- 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
E-Verify Participation: As part of the I9 verification of authorization to work in the US, Apogee participates in E-Verify. To learn more about E-Verify please review this poster.
Apogee Therapeutics is proud to be an Equal Opportunity employer. All qualified applicants will receive consideration for employment without regard to sex, gender identity, sexual orientation, race, color, religion, national origin, disability, protected Veteran status, age, or any other characteristic protected by law.
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