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Spyre Therapeutics · 2 hours ago

Senior Manager, Medical Writer

United States

Full-time

Remote

Senior Level, Lead/Staff

$165K/yr - $185K/yr

8+ years exp

Spyre Therapeutics is a clinical-stage biotechnology company pioneering long-acting antibodies and antibody combinations to redefine the standard of care for inflammatory bowel disease and rheumatic diseases. As Senior Manager, Medical Writer, you will lead or contribute to clinical and regulatory documents, ensuring timely deliverables and collaboration with cross-functional teams.

BiotechnologyTherapeutics

Responsibilities

Lead projects, submissions or programs independently

Provide medical writing strategy to program teams, ensuring business goals and regulatory needs are met

Author key clinical, nonclinical and regulatory documents, including but not limited to clinical study protocols, amendments, IBs, CSRs, data summaries, CTD summaries, briefing books and meeting responses

Develop timelines in collaboration with our team. Plan for required data with SMEs, if applicable

Co-author documents with relevant cross-functional SMEs. Ensure required elements are clearly described and documents comply with ethical and regulatory standards. Manage review cycles (including collaboration with stakeholders to address comments)

Coordinate QC, finalization and publication of documents

Review or contribute to supporting study documents, including but not limited to informed consent forms, study charters, or pharmacy manuals, if required

Ensure key messages are clear and consistent across and within documents

Represents the medical writing function in cross-functional teams

Provide status updates to keep teams, department, and leadership informed

Identify risks and contribute to risk mitigation or contingency planning for submission activities

Proactively contribute to process improvements and standards across the team. Develop or maintain document templates, job aids, tools, and training materials

Advocate across cross-functional teams to implement industry best practices such as lean authoring and strategic review

Qualification

Regulatory medical writingClinical document authoringFDA regulationsProject managementWord processing softwareDocument management systemsLeadership skillsCollaboration skillsCommunication skillsInterpersonal skills

Required

Bachelor's degree in a scientific discipline, preferably in Pharmacy, Chemistry, Biology, or related field

A minimum of 8+ years of experience in relevant regulatory medical writing is required

Proven track record of program- and/or submission-level management

Ability to manage multiple projects and timelines simultaneously

Proven track record of leading and authoring high-quality clinical and regulatory documents, including for complex document types

Strong knowledge of global pharmaceutical regulations and guidelines, including FDA, EMA, and ICH requirements

Excellent leadership, collaboration, communication, and interpersonal skills (taking initiative, problem solving, conflict resolution, change management, strategic thinking)

Ability to meet deadlines and adapt to changing priorities

Expert in word processing software (eg, Office) and document management systems (eg, Veeva)

Preferred

Advanced degree (MS, PhD, MD, PharmD) is a plus

Knowledge of drug-drug and biologic-biologic combination products as well as the design of clinical studies for such products is a plus

Benefits

Market competitive compensation and benefits package, including base salary, performance bonus, equity grant opportunities, health, welfare & retirement benefits.

Unlimited PTO

Two, one-week company-wide shutdowns each

Commitment to provide professional development opportunities.

Remote working environment with frequent in-person meetings to address complex problems and build relationships.