The Senior Writer will collaborate with project teams on developing clinical documents in accordance with all applicable regulations, Good Clinical Practices, and Standard Operating Procedures (SOPs) on a clinical program. This position will report to the Director of Medical Writing.
- Produce high quality and on-time medical writing deliverables
- Lead development, including writing and project management of clinical regulatory and safety documents, including but not limited to clinical protocols, investigator’s brochures, clinical study reports, and other regulatory submission documents with minimal supervision.
- Collaborate effectively with Clinical Development, Biometrics, Clinical Operations, Regulatory Affairs, Translational Pharmacology, Pharmacovigilance, Translational Pharmacology, Program Management, Research, Quality, Corporate Communications, and external stakeholders as applicable
- Bachelor’s degree required; advanced degree in a relevant scientific/clinical/regulatory discipline preferred
- 3+ years of clinical/regulatory/safety writing experience
- Solid understanding of the basic principles of biochemistry and molecular biology
- Demonstrated ability to communicate and write clearly, concisely, and effectively
- Experience driving documents from start to finish with tight timelines and cross-functional study teams
- Impeccable attention to detail and ability to complete writing assignments independently in a timely manner
- Proficient in Microsoft Word, Excel, PowerPoint, PleaseReview, Sharepoint or other joint writing/editing tools
- Strong analytical skills and ability to interpret and present complex data clearly
- Independently motivated, and good problem-solving ability
- Aptitude for data compilation, analysis, and presentation
- Knowledge of Good Clinical Practices, FDA regulations, ICH guidelines, and the drug development process
- Master’s, PhD in Life Science, Chemistry, Pharmacy or equivalent, Pharm D
- Working knowledge of biologics development and manufacture, clinical research, study design, biostatistics, the regulatory environment, and medical terminology preferred
- Ability to manage multiple projects in a fast-paced and deadline-driven environment
- Knowledge of requirements for preparation of regulatory documents for INDs, CTAs, NDAs/BLAs and annual reports is a plus
CRISPR Therapeutics, Inc. is committed to equal employment opportunity and non-discrimination for all employees and qualified applicants without regard to a person's race, color, gender, age, religion, national origin, ancestry, disability, veteran status, genetic information, sexual orientation or any characteristic protected under applicable law.
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