Crinetics Pharmaceuticals is dedicated to advancing treatments for rare endocrine diseases, aiming to enhance patients' lives by developing innovative therapies
Manager, Trial Disclosure, Medical Writing Operations
Location
California
Posted
27 days ago
Salary
$130K - $154K / year
Seniority
Lead
Job Description
Job Requirements
- Bachelor’s Degree required; advanced degree in life sciences, public health, regulatory science, or related discipline preferred (eg, MS, MPH, PharmD, PhD)
- 7-years’ experience in Trial Disclosure desired with flexibility of combined experience in closely related industry field with some responsibility for disclosure and results reporting activities (eg, clinical operations or regulatory affairs)
- Experience managing CT.gov on behalf of an organization, including 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 (eg, CT.gov, CTIS)
- Experience developing/managing 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.
Benefits
- discretionary annual target bonus
- stock options
- ESPP
- 401k match
- top-notch health insurance plans for employees (and their families) to include medical, dental, vision and basic life insurance
- 20 days of PTO
- 10 paid holidays
- winter company shutdown
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