Associate Director, Medical Writing

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. We were founded by a dedicated team of scientists with the simple belief that better therapies developed from rigorous innovation can lead to better lives. Our work continues to make a real difference in the lives of patients. We have a prolific discovery engine and a robust preclinical and clinical development pipeline. We are driven by science with a patient-centric and team-oriented culture. This is an exciting time to join Crinetics as we shape our organization into the world’s premier fully integrated endocrine company from discovery to patients. Join our team as we transform the lives of others.

Position Summary:

The Associate Director, Medial Writing will be responsible for writing, review, and approval of clinical and regulatory documents (e.g., Clinical Protocols, Investigator Brochures, Clinical Study Reports, Annual Reports, Regulatory Briefing Documents and Meeting Requests, and CTD summary and overview sections for INDs and NDAs). This position will be responsible for collaborating across functions for document development activities, including timeline setting and management, understanding the scientific importance of a broad spectrum of data, and adapting/managing key strategic messaging across documents. Qualified candidates will have experience overseeing outsourced medical writing projects and NDA experience.

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• Write and oversee the writing of clinical protocols, clinical study reports, investigator’s brochures, annual reports, IND and NDA summary sections, and other regulatory submission documents, as requested
• Proactively drive the document writing, review, and approval process in a collaborative manner
• Develop and/or maintain integrated timelines for document generation across the program in accordance with regulatory requirements (e.g., annual IB updates, CSRs in time for results reporting) and company goals (eg, target NDA/IND submission date; clinical protocols in time to meet first-subject, first-visit)
• Coordinate and/or manage review cycles to triage, incorporate, and resolve team comments, and lead discussion on document revision and finalization for both internally written and outsourced documents
• With Director support, manage complex, multi-document outsourced writing projects
• Serve as the program-level point person for medical writing guidance and document-related problem resolution
• Take the initiative to solve problems by exercising sound judgment and appropriate flexibility within a dynamic environment
• Provide input on processes, templates, and other business needs within the medical writing function
• Ability to quickly learn disease state and therapeutic paradigm to fully support the team in a scientific writing capacity and manage content and messaging across the program

• Other duties as assigned

Education and Experience:

• Bachelor’s degree required, advanced life sciences degree preferred.
• A minimum of 8 years regulatory medical writing experience in the biotech/pharmaceutical industry.  (An equivalent combination of experience and education may be considered.)
• Experience with writing sections of INDs/BLAs/NDAs/MAAs and an understanding of CTD structure and granularity requirements
• Extensive experience with clinical protocols and clinical study reports, including assembly of ICH appendices
• Experience using an electronic document management system as the primary tool to complete document generation, writing, review, and approval
• Knowledge of regulations relevant to medical writing
• Ability to manage/work on multiple writing projects at once while balancing overlapping timelines
• Ability to write clear, scientifically accurate text at a level appropriate to the audience and the project with careful attention to detail
• Demonstrated ability to collaborate across multiple scientific and operational functions to achieve timely document completion
• Solid understanding of statistical analysis as it pertains to clinical trials
• Working knowledge of GCP, GLP, GMP, and ICH guidelines and related FDA/EMA guidance on submission elements and integrated summaries of safety and of efficacy
• Excellent written and verbal communication skills
• Strong project management skills with ability to manage multiple projects and execute in adherence to timelines
• Excellent standard of written English, and ability to communicate fluently and effectively in English, both in w