Manager, Trial Disclosure, Medical Writing Operations
Crinetics Pharmaceuticals
June 27, 2026
Remote friendly (United States)
United States
$130,000 - $154,000 USD yearly
Operations
Position Summary
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. Ensures accurate, compliant public release of clinical trial information in collaboration with cross-functional teams. Redacts documents per company confidential information (CCI) and the General Data Protection Regulation (GDPR).
Essential Job Functions and Responsibilities
- Ensure compliance with clinical trial transparency laws/frameworks (e.g., FDAA 801 and Final Rule; CTR 536/2014).
- Partner with cross-functional teams to develop and post approved clinical trial and results content.
- Develop and implement internal procedures, processes, templates, and tools for clinical trial disclosure.
- Develop and maintain CCI documents (process owner).
- Prepare redacted documents for public postings by identifying and removing CCI and personally protected information (PPI) under GDPR and other privacy laws.
- Apply logic, attention to detail, critical thinking, good judgment, and follow-up to deliverables.
- Use a customer-service mindset with cross-functional teams.
- Other duties as assigned.
Required
- Bachelor’s degree required; MS/MPH/PharmD/PhD preferred.
- 7 years’ trial disclosure experience desired (or closely related experience with disclosure/results reporting responsibilities).
- Experience managing CT.gov and posting results to CTIS within regulatory timelines.
- Ability to translate protocols and interpret clinical study reports into disclosure postings (e.g., CT.gov/CTIS).
- Experience managing document review/approval processes for redacted CCI and PII.
- Collaboration, strong project management, controlled electronic document management system experience.
- Ability to incorporate/automate technologies; excellent English communication.
Preferred
- Experience as process owner for development/maintenance of CCI documentation.
Benefits (as stated)
- Discretionary annual target bonus; stock options; ESPP; 401k match; medical/dental/vision/basic life; 20 days PTO; 10 paid holidays; winter company shutdown.
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. Ensures accurate, compliant public release of clinical trial information in collaboration with cross-functional teams. Redacts documents per company confidential information (CCI) and the General Data Protection Regulation (GDPR).
Essential Job Functions and Responsibilities
- Ensure compliance with clinical trial transparency laws/frameworks (e.g., FDAA 801 and Final Rule; CTR 536/2014).
- Partner with cross-functional teams to develop and post approved clinical trial and results content.
- Develop and implement internal procedures, processes, templates, and tools for clinical trial disclosure.
- Develop and maintain CCI documents (process owner).
- Prepare redacted documents for public postings by identifying and removing CCI and personally protected information (PPI) under GDPR and other privacy laws.
- Apply logic, attention to detail, critical thinking, good judgment, and follow-up to deliverables.
- Use a customer-service mindset with cross-functional teams.
- Other duties as assigned.
Required
- Bachelor’s degree required; MS/MPH/PharmD/PhD preferred.
- 7 years’ trial disclosure experience desired (or closely related experience with disclosure/results reporting responsibilities).
- Experience managing CT.gov and posting results to CTIS within regulatory timelines.
- Ability to translate protocols and interpret clinical study reports into disclosure postings (e.g., CT.gov/CTIS).
- Experience managing document review/approval processes for redacted CCI and PII.
- Collaboration, strong project management, controlled electronic document management system experience.
- Ability to incorporate/automate technologies; excellent English communication.
Preferred
- Experience as process owner for development/maintenance of CCI documentation.
Benefits (as stated)
- Discretionary annual target bonus; stock options; ESPP; 401k match; medical/dental/vision/basic life; 20 days PTO; 10 paid holidays; winter company shutdown.