Non-Clinical Medical Writer (Contract)

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 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.

Position Summary

The Nonclinical Medical Writer is responsible for the development of nonclinical documents for submission to the relevant health authorities. Additionally, they will support the creation of publications and presentations, as needed. 

Responsibilities

• Author the nonclinical parts of regulatory documents in collaboration with nonclinical SMEs (i.e., toxicologist, clinical scientist, nonclinical scientists). Ensure the nonclinical sections of these documents are well-organized, accurate, up-to-date, consistent, compliant with applicable regulations, and written according to CRISPR Tx Medical Writing standards.
• Prepare timelines, lead drafting and review cycles of nonclinical regulatory documents (e.g., Modules 2.4 and 2.6, nonclinical briefing books, investigator brochures)
• Attend Pharmacology, Toxicology research meetings to understand the nonclinical problems and have an overview of the ongoing nonclinical study timelines.
• Participate in maintaining critical document timelines by working with the Project Manager, Regulatory Lead, Head of Pharmacology, Toxicology, and other medical writers to ensure project deadlines are met.
• Collaborate with project teams to ensure project deadlines are met by providing content development support, research, and editing functions for each program.
• Support the development and maintenance of nonclinical template documents.
• Collaborate with Reg Ops and nonclinical SMEs to ensure the availability of nonclinical documentation before a regulatory submission (e.g., support Module 4 preparation)
• Review and edit in-house nonclinical study reports that are intended for regulatory submission, to ensure quality of final documentation (non-GLP, toxicology, pharmacology, and pharmacokinetics where appropriate)
• Perform SOP-driven quality control (QC) support for regulatory documents

Minimum Qualifications

• Bachelor's degree in life science/medical discipline with 8-10 years of experience, or Master’s/PhD with 3-5 years of experience in nonclinical medical writing
• Direct experience as a main author for cell and gene therapy drug product IBs, CTAs, INDs, or briefing books for regulatory interactions (e.g. INTERACT, pre-IND, Scientific Advice, EOP meetings, etc.)
• Direct experience working with multiple regulatory health authorities (e.g. FDA, EMA, TGA, MHRA, PMDA, HC, etc.)
• Familiarity with ICH and FDA guidelines related to non-clinical functions, including eCTD modules
• Proficiency in MS Office software applications such as Outlook, Excel, and PowerPoint, excellence in word
• Collaborator and good communication skills
• Flexible attitude, able to manage multiple parallel tasks.
• Knowledge of nonclinical safety, knowledge of GLP in biologics (gene and cell therapy preferred)
• Excellent written and verbal communication skills
• Experience with Veeva Vault, Kivo, Please Review, or similar preferred.
• Experience writing for biologics preferred with ability to accurately summarize data to draw a conclusion.
• Basic understanding of scientific methodology, with the ability to understand clinical development and eCTD structure, including the phases, processes, and techniques used within a clinical development environment from protocol design through regulatory submission.
• Ability to understand FDA/international regulations, ICH guidelines, and applicable US/international regulatory processes related to document preparation and production (including CTDs)
• Ability to proofread documents for compliance with internal and external guidance documents.
• Ability to work precisely according to procedures and regulations.  
• Ability to work autonomously, as well as in a team; ability to prioritize and multi-task successfully in a fast-paced environment.

Preferred Qualifications

• Knowledge of biologics development, nonclinical research and pharmacology and toxicology study design, the regulatory environment, knowledge of nonclinical and clinical terminology preferred.
• Experience with mRNA, LNP, siRNA, or nucleotide technologies
• Experience or willingness to learn novel platform technologies within the biotechnology industry
• Experience authoring or communicating gene editing and genomics analysis, or other novel biotechnology modalities

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.

Contract rate of $150 to $170 per hour.

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