Lead, Medical Writing
Lead, Medical Writing
Reporting to VP of Regulatory Science, this role provides medical writing leadership and support for clinical and regulatory documentation required for the conduct and submission of results of clinical trials. This position interacts with other clinical development functions in order to create/author/manage documentation required to support clinical trials and regulatory submissions. He/she will also lead strategy discussions related to document development and related timelines. As the Medial Writing Lead, he/she is the scientific contributor and subject matter expert for clinical regulatory documentation. He/she will also manage external vendors and personnel as needed to address all medical writing and documentation needs.
- As the Lead writer for multiple clinical development programs, independently prepare clinical regulatory documents, including protocols, study reports, investigator’s brochures, and sections of regulatory submissions
- Participate in developing key messages for complex clinical regulatory documents
- Provide medical writing input for study designs and statistical analysis plans
- Provide expert review of documents
- Provide expert-level input to teams that work on SOPs and process improvements, and integrations of new tools and technologies
- Minimum of 5 years of industry experience; experience in CNS programs strongly preferred
- Extensive experience writing and editing clinical regulatory documents; inclusive of eCTD for regulatory submission
- Advanced understanding of drug development, clinical research, and regulatory requirements
- Participation or has served as Medical Writing Lead for a submission of an NDA, sNDA, and/or MAA
- Prioritization skills and ability to handle multiple complex projects
- Ability to analyze, interpret, and summarize highly complex data
- Strong computer skills including knowledge of Excel, Word, PowerPoint, Outlook and MS Project.
- Ability to manage external vendors and personnel
- Ability to form working relationships, and work through conflicts
- Excellent written communication skills and attention to detail
- Desire to work in a fast-pace, dynamic environment
- Excellent communication and presentation skills
- A high degree of autonomy; takes accountability for work
- Very organized and efficient; produces high-quality deliverables
- Knowledge of web-based communication tools for conferences
- Working knowledge of medical terminology and experience with clinical research
Master’s degree required, Ph. D preferred
Relevant professional certifications a plus
Cerevel is an Equal Opportunity Employer and does not discriminate on the basis of race, religion, color, sex, gender identity, sexual orientation, age, non-disqualifying physical or mental disability, national origin, veteran status or any other characteristic protected by applicable law.
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