Senior / Manager, Medical Writing

Role Summary

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.

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

Qualifications

• 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

Skills

• Scientific/medical writing
• Communication (written and verbal)
• Interpersonal collaboration
• Data analysis and interpretation
• Regulatory documentation knowledge
• Document management and organization

Education

• Bachelor's degree in a relevant discipline (required)
• PhD in molecular biology, genetics, or related life sciences (preferred)