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Senior Manager, Medical Writing

3 weeks ago
United States
Full-time
Lead
Technical Project Manager
Project and Program Management
Apply Now
Apogee Therapeutics

Apogee Therapeutics

Apogee Therapeutics, Inc. is a biotechnology company dedicated to developing innovative biologics for the treatment of atopic dermatitis, chronic obstructive pulmonary disease, and other inflammatory and immune diseases with high unmet needs. Their goa...

Biotechnology
1-10
Founded 2022
$169M raised
View All Jobs 22

Description

  • Prepare, review, and edit scientifically accurate, submission-ready clinical and regulatory documents, including protocols, investigator's brochures, clinical study reports, briefing documents, and Module 2 summaries.
  • Coordinate deliverables, writing processes, and timelines with cross-functional teams and hold contributors accountable to document milestones.
  • Negotiate deliverable scope and schedules with functional teams to resolve conflicts and keep document projects on track.
  • Ensure medical writing work complies with relevant regulatory guidelines, industry best practices, and ethical standards.
  • Maintain and improve document templates, style guides, and standard operating procedures to support consistency and quality.
  • Oversee planning, coordination, and execution of medical writing projects handled by external vendors and consultants.
  • Use AI-enabled tools to improve efficiency and quality while preserving scientific rigor and regulatory compliance.
  • Help define and implement responsible AI best practices within medical writing workflows.
  • Provide guidance and support to less experienced medical writers and external vendors.
  • Represent Medical Writing in team meetings and contribute to document-related project decisions.

Requirements

  • Bachelor's degree in science; advanced degree is a plus.
  • 8+ years of medical writing experience in the pharmaceutical or biotech industry.
  • Ability to understand, critically analyze, and interpret data and summarize complex results clearly and accurately.
  • Strong interpersonal and communication skills with experience influencing others and building positive relationships.
  • Ability to work across multiple teams and manage competing priorities in a fast-paced startup environment.
  • Experience independently authoring a range of scientific documents and overseeing third-party authorship.
  • Detail-oriented with exceptional organizational and project management skills.
  • Proficiency with scientific writing tools, including Microsoft Office, document management systems, and reference management software.
  • Ability to quickly learn new software applications.

Benefits

  • Market-competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare, and retirement benefits.
  • Anticipated salary range of $160,000-$180,000 per year.
  • Three weeks of PTO.
  • Two one-week company-wide shutdowns each year.
  • Dedicated paid sick leave.
  • Professional development support and access to resources for growth.
  • Regular all-team in-person meetings to build relationships and solve problems.

Interested in this position?

Apply directly on the company website

Apply Now

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