Senior/ Principal Medical Writer

Job Description

Job Description

Company Overview

Since its inception over a decade ago, CRISPR Therapeutics has 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 Therapeutics has established strategic partnerships with leading companies including Bayer and Vertex Pharmaceuticals.

CRISPR Therapeutics AG is headquartered in Zug, Switzerland, with its wholly-owned U.S. subsidiary, CRISPR Therapeutics, Inc.

and R&D operations based in Boston, Massachusetts and San Francisco, California, and business offices in London, United Kingdom.

Position Summary

The Senior / Principal 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 Senior 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 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.

Minimum Qualifications

• 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

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

Competencies

• 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.

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.

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.

To view our Privacy Statement, please click the following link : http : / / www.crisprtx.com / about -us / privacy-policy

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