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. Crinetics is known for its inclusive workplace culture. We are also a dog-friendly workplace. 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:

Reporting to the Senior Director, Medical Writing, the Director, Medical Writing will be responsible for overseeing and managing the scientific medical writing group on a day-to-day basis. The Director, Medical writing will work closely with the Senior Director to ensure the group is adequately resourced and supported to deliver high-quality documents to the program development teams. This individual will also independently contribute to program-based medical writing projects with responsibility for writing, review, and approval of clinical and regulatory documents (e.g., Clinical Protocols, Investigator Brochures, Clinical Study Reports, Regulatory Briefing Documents, and CTD summary and overview sections for INDs and NDAs). Qualified candidates will have experience managing medical writers and collaborating across functions for document development activities. This leader will exercise sound judgement to solve acute challenges while collaborating with the Senior Director to institute iterative improvements to department operations (eg, standard timelines, templates, metrics, SOPs).

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• Provide day-to-day management, leadership, and support to the scientific medical writing group by exemplifying the medical writing role through actions and behaviors
• Focus on immediate and short-term (<2 years) strategic planning horizon
• Oversee/develop department policies and procedures to achieve department and corporate goals
• Ensure adequate resources are in place to successfully complete medical writing projects
• Proactively drive document writing, review, and approval processes through collaboration and best practices development
• Provide structure, mentorship, and guidance to individual contributors tasked with new project experiences (e.g., IND, NDA, MAA
• 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
• Contribute to the improvement of Medical Writing processes and systems
• Participate in the headcount planning process and determine department needs to support ongoing projects/programs
• Other duties as assigned

Education and Experience:

Required:

• Bachelor’s degree.
• A minimum of 12 years regulatory medical writing experience in the biotech/pharmaceutical industry.  (An equivalent combination of experience and education may be considered.)
• A minimum of 8 years of experience in a leadership role is required
• 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
• Excel