The Opportunity:

The Senior Manager, Medical Writing is responsible for independently authoring and delivering high-quality routine clinical and regulatory documents and represents Medical Writing as a cross-functional team member for clinical study-level activities. This position will work directly with the Director, Medical Writing.

Your Role:

Independently writing and delivering high-quality clinical and regulatory documents (e.g., clinical study protocols, clinical study reports, investigator's brochures, integrated summaries, and sections of regulatory submissions) in partnership with internal cross-functional team members.
Coordinating effective document development, review, and approval.
Overseeing medical writing vendor writers for individual projects, as needed.
Actively contributing to development of processes and procedures to improve departmental and cross-functional workflows.
Building relationships and working collaboratively with study team members.
Reviewing study and program-level documents for clarity, accuracy, and consistency.
Developing in-depth study-level and program knowledge.
Contributing scientific knowledge and analytical skills to the production of documents.
Participating in developing key messages for clinical regulatory documents.
Developing document timelines and communicating with team members to maintain awareness of expectations, milestones, and deliverables.
Leading development of clinical trial registry postings for assigned studies.
Navigating an electronic document management system and related tools to develop clinical documents.

Your Background:

Bachelor's degree in relevant discipline required. PhD in molecular biology, genetics, or a related life sciences field preferred (or equivalent degree).
5+ years of experience in the pharmaceutical/biotechnology industry as a medical writer.
Self-motivated and nimble with the ability to excel in a fast-paced environment.
Excellent written and verbal communication skills.
Strong interpersonal skills.
Experience producing high-quality scientific/medical documents.
Ability to analyze, interpret, and summarize clinical data.
Basic understanding of drug development, clinical research, study design, biostatistics, pharmacokinetics, regulatory requirements, and medical terminology.
Strong project management and organizational skills.
Initiative and creativity in solving routine problems for individual documents and in identifying process improvements within the Medical Writing department.
Attention to detail related to consistency, grammar, syntax, and scientific accuracy.
Proficiency in word processing, templates, table/figure creation, and literature searches.

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Relay Therapeutics

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Senior Manager, Medical Writing