Manager, Trial Disclosure, Medical Writing Operations

Crinetics is a pharmaceutical company based in San Diego, California, developing much-needed therapies for people with endocrine diseases and endocrine-related tumors. Founded by a dedicated team of scientists, we pursue rigorous innovation to improve lives. Our discovery engine and robust preclinical/clinical pipeline drive a patient‑centric, team‑oriented culture in a fully integrated endocrine environment. We also celebrate an inclusive, dog‑friendly workplace. Position Summary The Manager of Medical Writing Operations - Trial Disclosure is responsible for clinical trial transparency and disclosure activities, including initial trial postings, results postings, document redaction, and plain language summary development. The role ensures accurate and compliant public release of clinical trial information while working closely with cross‑functional teams. It also manages redacted documentation in accordance with company confidential information (CCI) and the General Data Protection Regulation. Essential Job Functions and Responsibilities Ensure company compliance with clinical trial transparency laws and requirements, applying expert knowledge of FDAA 801, Final Rule, and CTR 536/2014. Work with cross‑functional teams to develop content for clinical trial and results postings and post all approved materials in accordance with regulations. Develop and implement internal procedures, processes, templates, and tools for all aspects of clinical trial disclosure. Develop and maintain CCI documents (process owner). Prepare redacted documents for postings, ensuring CCI and personal protected information (PPI) are identified and removed in compliance with GDPR and other privacy laws. Apply logic, attention to detail, critical thinking, good judgment, and follow‑up skills to every deliverable and situation. Approach all engagements with cross‑functional team members with a customer‑service mindset. Other duties as assigned. Education and Experience Bachelor’s Degree required; advanced degree in life sciences, public health, regulatory science, or related discipline preferred (MS, MPH, PharmD, PhD). 7‑years’ experience in Trial Disclosure desired, with flexibility for combined experience in closely related industry fields with some responsibility for disclosure and results reporting activities. Experience managing CT.gov on behalf of an organization, ensuring regulatory timelines are met for trial disclosure and results reporting. Experience posting trial results to CTIS in accordance with regulatory timelines. Demonstrated experience independently translating clinical protocols into accurate disclosure postings and interpreting clinical study reports to create accurate results postings within the parameters of the disclosure platform. Experience developing/managing the process for development, review, and approval of documents with redacted (red box and black box) company confidential information and personally identifiable information. Demonstrated ability to collaborate across functional scientific and operational disciplines to drive alignment on process and content. Strong project management skills with ability to manage multiple projects with overlapping timelines while adhering to regulatory requirements for each individual deliverable. Experience with controlled electronic document management systems. Ability and adaptability to incorporate existing or new technologies to automate current manual processes. Excellent verbal and written communication skills in English. Experience as process owner for development and maintenance of company confidential information documentation preferred. Physical Demands and Work Environment On a continuous basis, sit at a desk for a long period of time; intermittently answer telephone and write or use a keyboard to communicate through written means. Some walking and lifting up to 25 lbs may be required. The noise level in the work environment is typically low to moderate. Reasonable accommodations may be made for individuals with disabilities. Biological or chemical laboratory experience may be needed; environmental health and safety requirements also apply. Travel: Up to 5% of the time. Benefits Salary Range: $130,000 – $154,000. Discretionary annual target bonus, stock options, ESPP, and 401(k) match. Top‑notch health insurance plans for employees and families (medical, dental, vision, basic life insurance). 20 days of PTO, 10 paid holidays, and a winter company shutdown. Equal Opportunity Employer Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and applicants without regard to unlawful considerations of sex, sexual orientation, gender, pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion, disability, marital and civil union status, age, genetic information, veteran status, or any other attribute protected by applicable laws. #J-18808-Ljbffr