Senior/ Principal Medical Writer
CRISPR Therapeutics
- Boston, MA
- Permanent
- Full-time
- Produce high quality and on-time medical writing deliverables.
- Lead development, including writing and project management, of clinical regulatory documents, including but not limited to clinical study protocols, investigator’s brochures, clinical study reports, safety data summaries, clinical and nonclinical components of a new IND application with some or minimal supervision.
- Collaborate effectively with Clinical Development, Biometrics, Clinical Operations, Regulatory Affairs, Clinical/Translational Pharmacology, Pharmacovigilance, Quality, and external stakeholders as applicable.
- Bachelor’s degree required; advanced degree in a relevant scientific/clinical/regulatory discipline strongly preferred.
- Senior Medical Writer – 7 to 10 years of relevant experience or 4-6+ years with advanced degree, and at least 3 years of medical writing experience
- Principal Medical Writer– 10 to 12+ years of relevant experience or 8-10+ years with advanced degree, and at least 5 years of medical writing experience
- Regulatory writing experience with specific expertise in writing clinical study protocols and amendments, investigator’s brochure, clinical study reports and safety data summaries.
- Solid understanding of the basic principles of biochemistry and molecular biology
- Demonstrated ability to communicate and write clearly, concisely, and effectively
- Experience driving the completion of document writing from start to finish with tight timelines and through close collaboration with cross-functional study teams
- Impeccable attention to detail and a keen ability to complete complex writing assignments with minimal supervision in a timely manner
- Proficient in Microsoft Word, Excel, PowerPoint, PleaseReview, SharePoint or other joint writing/editing tools
- Independently motivated, self-starter
- Exceptional problem-solving capabilities
- Aptitude for data compilation, analysis, and presentation
- Knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process
- Ability to manage multiple projects in a fast-paced and deadline-driven environment
- Working knowledge of biologics development and manufacture, clinical research, study design, biostatistics, the regulatory environment, and medical terminology preferred
- Knowledge of requirements for preparation of regulatory documents for INDs, CTAs, NDAs/BLAs and annual reports is a plus
- Collaborative – Openness, One Team
- Undaunted – Fearless, Can-do attitude
- Results Orientation – Delivering progress toward our mission. Sense of urgency in solving problems.
- Entrepreneurial Spirit – Proactive. Ownership mindset.