Crinetics Pharmaceuticals

Manager, Trial Disclosure, Medical Writing Operations

Remote, USA

Sponsorship not specified$130k-$154kDetected 79 days ago

Project ManagementPublic HealthFDA RegulatoryAnimal StudiesCommunicationCollaborationCritical ThinkingPlain LanguageAdaptabilityRegulatory Affairs

About the role

The role is responsible for ensuring accurate and compliant public release of clinical trial information while working in close collaboration with cross-functional teams.
This role is also responsible for redacted documentation in accordance with company confidential information (CCI) and the General Data Protection Regulation.
Essential Job Functions and Responsibilities:

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 maintains CCI documents (process owner).
Prepare redacted documents for postings ensuring CCI and personal protected information (PPI) in accordance with the General Data Protection Regulation in the EU and other privacy laws are identified for redaction and redacted from documents that are posted publicly.
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.

Ensure company compliance with clinical trial transparency laws and requirements by applying expert knowledge of key regulatory frameworks, including FDAA 801 and Final Rule and CTR 536/2014.
Some walking and lifting up to 25 lbs. may be required.
The physical demands described above are representative of those that must be met by an employee to successfully perform the essential functions and responsibilities of this job.
You may be required to travel for up to 5% of your time.
Experience with controlled electronic document management systems.

Experience as process owner for development and maintenance of company confidential information documentation preferred.

Apply logic, attention to detail, critical thinking, good judgement, and follow-up skills to every deliverable and situation.
Ability and adaptability to incorporate existing or new technologies to automate current manual processes.
Excellent verbal and written communication skills in English.

The salary range for this position is: $130000 - $154000.
In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match.
The final salary offered to a successful candidate will be dependent on several factors that may include but are not limited to the type and length of experience and education.
Crinetics Pharmaceuticals is a multi-state employer, and this salary range may not reflect positions that work in other states.
Your recruiter can share more about the specific salary range during the hiring process.
The Anticipated Base Salary Range:

B achelor's Degree required; advanced degree in life sciences, public health, regulatory science, or related discipline preferred (eg, MS, MPH, PharmD, PhD)

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.

Employer:
Crinetics is proud to be an Equal Opportunity Employer. We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.
Crinetics is proud to be an Equal Opportunity Employer.
We provide equal employment opportunities to all employees and employment applicants without regard to unlawful considerations of sex, sexual orientation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union status, age, genetic information, veteran status or any personal attribute or characteristic that is protected by applicable local, state or federal laws.

tation, gender (including gender identity and/or expression), pregnancy, race, color, creed, national or ethnic origin, citizenship status, religion or similar philosophical beliefs, disability, marital and civil union s

This listing is sourced directly from Crinetics Pharmaceuticals's careers page and normalized into a canonical job model.