Principal Medical Writer leading CMC regulatory submissions for Veristat’s life - sciences clients. Authoring Modules 3 and 2.3 while guiding project teams and mentoring regulatory writers.
About the role
- Senior Medical Writer leading clinical regulatory and clinical document authorship for Veristat, a life-sciences consultancy accelerating therapies. Managing projects, teams, clients, and submission deliverables.
Responsibilities
- Contribute to authorship of clinical and regulatory documents across different service lines
- Lead smaller projects as project lead and interface directly with clients
- Support larger, more complex engagements as part of a larger delivery team
- Lead internal project teams and anticipate the effects of writing conventions on health authority approval or acceptance
- Develop submission-level documents
- Develop clinical documents such as Clinical Study Reports, Investigator Brochures, protocols, ISS, and ISE
- Synthesize data across multiple sources and documents to create summary reports
- Conduct or lead a CRM and lead project teams to consensus
- Present ideas and suggestions using logical arguments while responding constructively to opposing views
- Develop professional client relationships to support business relationships and maintain industry knowledge
- Identify and institutionalize effective work practices to ensure consistent performance
Requirements
- Bachelor’s degree
- 3+ years of regulatory writing experience or equivalent experience with clinical-related documentation
- Understanding of regulatory authority guidelines and requirements
- Experience developing submission-level documents
- Experience developing Clinical Study Reports, Investigator Brochures, protocols, ISS, and/or ISE
- Intermediate proficiency with Microsoft Word, including editing tools, creating and modifying tables, and inserting figures
- Knowledge of document management techniques
- Strong understanding of the document creation process and drug development lifecycle
- Ability to synthesize data across multiple data sources and documents
- Ability to conduct or lead a CRM and lead a project team to consensus
- Ability to use logical arguments to persuade others and respond positively to opposing views
- Ability to develop professional client relationships
- Ability to identify and institutionalize effective work practices
Benefits
- Remote working
- Flexible time off
- Paid holidays
- Medical insurance
- Tuition reimbursement
- Retirement plans
- Applicable bonus
Job title
Job type
Experience level
Salary
Degree requirement
Location requirements
Report this job
Found something wrong with the page? Please let us know by submitting a report below.
Medical Writer developing clinical protocols and regulatory documents for Syneos Health’s life sciences clients. Partnering with Clinical Scientists across oncology, hematology, and cell therapy studies.
Principal Medical Writer leading clinical regulatory documentation for Veristat’s life - science clients. Authoring submissions, leading project teams, and mentoring medical writers.
Senior Medical Writer creating manuscripts, abstracts, posters, and slide decks for Red Nucleus’s life sciences clients. Supporting medical communications and publication projects.
Principal Medical Writer preparing regulatory documents and medical communications for Veristat’s life - sciences therapy development programs. Interpreting scientific and statistical information under ICH guidelines.
Senior Medical Writer preparing regulatory documents and medical communications for Veristat’s life - sciences therapy development programs. Supporting global clinical and regulatory submissions under ICH guidelines.
Medical Writer II conducting literature research and developing medical publications, reports, and commercialization materials. Supporting EVERSANA’s life sciences clients, projects, and healthcare innovation.
Medical Writer II developing clinical protocols and regulatory documents for Syneos Health, a life sciences services organization. Leading medical writing deliverables across clinical studies and regulatory submissions.
Senior medical writer leading regulatory documents for Syneos Health’s integrated life sciences services. Preparing submissions, clinical reports, and safety materials for Phase 2 and 3 studies.
Medical Writer generating synthetic clinical trial data and authoring CSRs. Helping Mercor train frontier AI models through expert clinical documentation.