Job Description

Medical Writer/Senior Medical Writer (Healthcare) Job Description: Company Overview Since its inception over a decade ago,CRISPR Therapeuticshas transformed from a research-stage company advancing programs in the field of gene editing, to a company with a diverse portfolio of product candidates across a broad range of disease areas including hemoglobinopathies, oncology, regenerative medicine, cardiovascular and rare diseases. The Nobel Prize-winning CRISPR science has revolutionized biomedical research and represents a powerful, clinically validated approach with the potential to create a new class of potentially transformative medicines. To accelerate and expand its efforts,CRISPR Therapeuticshas established strategic partnerships with leading companies including Vertex Pharmaceuticals.CRISPR Therapeutics AGis headquartered inZug, Switzerland, with its wholly-ownedU.S.subsidiary,CRISPR Therapeutics, Inc., and R&D operations based inBoston, MassachusettsandSan Francisco, California, and business offices inLondon, United Kingdom. Position Summary The Medical Writer/ Senior Medical Writer will collaborate with project teams on developing clinical and regulatory 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. Responsibilities 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 noncl inical 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. Minimum Qualifications Bachelor's degree required; advanced degree in a relevant scientific/clinical/regulatory discipline strongly preferred Medical Writer - 5 to 7 + years of relevant experience or 3 - 5 + years with advanced degree 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 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 , Share P oint or other joint writing/editing tools Independently motivated, self-starter E xceptional 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 Preferred Qualifications 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 Results Orientation - Delivering progress toward our mission. Sense of urgency in solving problems. CRISPR Therapeutics believes in fostering a dynamic workplace that balances remote work flexibility with the benefits of in-person interactions. Our employees work at least three days on-site, creating a collaborative work environment, where we cultivate mentorship opportunities, increase cross-functional communication and offer opportunities for our employees to connect. Certain lab based and manufacturing positions are located fully on-site. 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. #J-18808-Ljbffr Crispr Therapeutics Inc in

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