Manager, Medical Writing

Relay Therapeutics•Cambridge, MA

6d•$107,000 - $152,000

About The Position

The 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.

Requirements

Bachelor's degree in relevant discipline required. PhD in molecular biology, genetics, or a related life sciences field preferred, (or equivalent degree).
3+ years of experience in the pharmaceutical/biotechnology industry as a medical writer
Self-motived 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

Responsibilities

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