Senior Manager - Medical Writing Operations

5 days ago

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Apogee Therapeutics

WebsiteLinkedInAll Job Openings

Immunology & Inflammation

51 - 200 employees

🧬 Biotechnology

💊 Pharmaceuticals

💰 $149M Series B on 2022-12

Description

• We are seeking a Senior Manager, Medical Writing Operations to be responsible for creating and managing documents for global clinical trial disclosure and data transparency activities per applicable laws, regulations, and policies, and will also have authoring and oversight responsibilities related to documents and processes that are in scope for the Medical Writing department. • This role will serve as a subject matter expert and primary point of contact for transparency and disclosure activities (eg, clinical trial results postings, document redactions, and plain language summaries) and will partner with team members in relevant functional areas and manage vendors who are directly involved in activities related to Medical Writing. • The successful candidate must be flexible, detailed-oriented, self-directed, and must manage workload to meet submission timelines across all company programs. • Contribute to the development of global clinical trials transparency and disclosure strategy, objectives, capabilities, and policy • Lead teams in the preparation and maintenance of CCI and PPD rules across programs, ensuring consistency of publicly disclosed information across countries, registries, databases, and documents • Manage the preparation of plain language summaries and redaction of clinical documents in accordance with regional and global regulations • Stay current on evolving requirements related to clinical trials transparency and disclosure, and ensure organizational compliance • Prepare, review, and edit high-quality, scientifically accurate, and submission-ready documents including, but not limited to study protocols, investigator’s brochures, and clinical study reports • Negotiate with functional areas regarding deliverables and timelines to meet conflicting demands, removing barriers, and using creativity to ensure teams achieve document-related project goals • Oversee the planning and coordination of Medical Writing projects by external vendors to ensure milestones are met • Develop and/or maintain regulatory style guide and Medical Writing-related SOPs, templates, work instructions, and user guides to ensure consistency and quality in written materials

Requirements

• Bachelor’s degree in science (advanced degree is a plus) • Must have a minimum of 4 years of experience as a regulatory or medical writer, with at least 2 years of global clinical trials transparency/disclosure process and strategy experience in the biotechnology or pharmaceutical setting • Self-starter with strong planning, organizational, and project management skills, along with initiative and ability to be productive independently • Outstanding interpersonal and communication skills, with experience interacting with and influencing people, and building strong, positive relationships • Ability to evaluate and recommend process improvements and suggest/implement best practices • Proven ability to adapt to change and uncertainty as projects evolve or shift and to multi-task and adjust priorities quickly while working under tight deadlines

Benefits

• 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