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 of Medical Writing Operations (AD MWO) is responsible for heading the Medical Writing Operations Group in a fast-paced, dynamic environment with tight timelines. The AD MWO oversees and conducts document quality review (correctness of content) and document editing for style. In addition, the AD MWO oversees and conducts the writing, review, and approval of plain language documents (e.g., informed consent forms and layperson protocol synopses). The AD MWO collaborates with IT to maintain medical writing systems and will have a role in identifying innovative solutions to advance future capabilities and efficiencies of the Medical Writing Department. The AD MWO manages both full‑time and contract operational resources, including assessing and proposing future resource needs. Success in this role requires flexibility, creativity, and commitment to accomplish tasks despite changes in upstream and downstream timelines.

Essential Job Functions and Responsibilities:

These may include but are not limited to:

• Manage full-time and contract document quality control reviewers and plain language writers.
• Manage processes including timing and duration of quality control review (correctness of content) and editing (style guide conformance, clarity of content) among competing priorities across multiple programs.
• Collaborate across relevant functions (e.g., assigned QC resource, Medical Writing, Regulatory Affairs, Regulatory Operations) to ensure timelines are met.
• Conduct quality review of medical writing documents.
• Manage/create supporting documents such as tracked-change versions for amended documents (e.g., protocols, IBs) and separate synopses based on approved documents (e.g., protocols).
• Manage/write plain language documents (e.g., informed consent forms and layperson protocol synopses).
• Develop and maintain Medical Writing Operations standards and procedures.
• In collaboration with IT, manage and maintain Medical Writing systems and software (e.g., EndNote and publication licensing software) and train users, as needed.
• Review document bibliographies, correct/add EndNote references, purchase licenses for new publications, and provide for submission preparations.

• Other duties as assigned.

Education and Experience:

• Bachelor’s degree required, advanced life sciences degree preferred, (e.g., MS, PhD). At least 10 years of experience in medical writing, medical writing operations, editing, and/or managing quality review in the biotech/pharmaceutical industry including at least 7 years leading teams and managing staff. An equivalent combination of experience and education may be considered.
• Experience with oversight and management of contractors and vendors.
• Ability to utilize new technology and systems in medical writing.
• Knowledge of medical science and nonclinical and clinical development.
• Ability to write clearly at a level appropriate to a scientific audience and to translate that writing to plain language documents (e.g., informed consent form, 2-page protocol synopsis, plain language summary of results). This may be accomplished through collaboration with in-house or contract plain language writers.
• Experience with electronic document control and management systems.
• Strong project management skills with ability to manage multiple projects with overlapping timelines while adhering to individual document timelines.
• Ability to assess workload and suggest prioritization to senior staff.
• Demonstrated ability to collaborate with other functions and contribute to solutions through independent thinking.
• Familiarity with statistical analysis.
• Working knowledge of GCP, GLP, GMP, and ICH guidelines and related FDA/EMA guidances on submission elements and integrated summaries of safety and of efficacy.
• Excellent written and verbal communicat