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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