Full-Time Principal Medical Writer, Nonclinical

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.

Position Summary:

The Principal Medical Writer, Nonclinical, will be responsible for writing nonclinical regulatory documents primarily focused on toxicology and safety pharmacology (e.g., nonclinical summaries and overviews for INDs and NDAs, nonclinical sections of Investigator’s Brochures, nonclinical sections of Briefing Documents for health authority meetings, and nonclinical sections of annual safety reports). This position will collaborate with nonclinical colleagues in the toxicology and safety pharmacology disciplines to write scientifically rigorous submission documents that support clinical and regulatory strategy.

Essential Job Functions and Responsibilities:

• These may include but are not limited to:
• Write toxicology and safety pharmacology sections of nonclinical summaries (Modules 2.6.1-2.6.7) and overview (Module 2.4), Investigator’s Brochures, nonclinical sections of Briefing Documents, and annual safety reports based on GLP and non-GLP source reports (Module 4)
• Drive document writing and review process.
• Develop and maintain timelines for document generation, revision, and completion (QC, format review, and approval) in collaboration with cross-functional team members.
• Coordinate and manage review cycles to triage, incorporate, and resolve team comments.
• Lead discussions on document revision and finalization.
• Coordinate and manage the writing and review of responses to health authorities requests for information relating to nonclinical data.
• Assist in managing outsourced writing projects.
• Assist in the development and maintenance of SOPs and writing tools, such as templates and style manuals.
• Take the initiative to solve problems by exercising sound judgment and appropriate flexibility within a dynamic environment.
• Undertake research in the therapy area to allow effective writing.
• Ensure writing meets scientific and literary standards and meets objectives.

Education and Experience:
Required:

• Bachelor’s degree with at least 8 years writing scientific and/or regulatory documents and a minimum of 3 years of experience in the biotech/ pharmaceutical industry.
• Knowledge of nonclinical requirements in support of first-in-human, mid- and late-stage clinical development.
• Experience writing nonclinical sections of INDs/NDAs/MAAs with a good understanding of eCTD structure and requirements (Modules 2.6 and 2.4)
• Direct experience writing nonclinical reports.
• Fluent in ICH S1-S13 guidance and ability to translate study outcomes into potential clinical risks.
• Ability to work and prioritize multiple projects at once while balancing multiple and overlapping timelines.
• Ability to write clearly at a level appropriate to the audience and the project with careful attention to detail and accuracy.
• Experience with electronic document control and management system.
• Strong project management skills with ability to manage multiple projects and execute in adherence to timelines.
• Ability to assess workload and suggest prioritization to senior staff.
• Demonstrated abilities in collaboration with others and independent thought.
• Familiarity with statistical analysis
• Excellent written and verbal communication skills
• Desire to work in a collaborative team setting.
• Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally

Preferred:

• Advanced life sciences degree (MS or PhD)
• Experience as nonclinical writer in regulatory affairs.
• Experience with Veeva RIM and StartingPoint Templates.
• Experience with global health authority requirements and expectations relating to nonclinical sections of dossiers.

Physical Demands and Work Environment:

Physical Activities: On a continuous basis, sit at 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. 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. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions and responsibilities.
Laboratory Activities (if applicable): Biology and chemical laboratory environment experience needed. Environmental health and safety requirements also apply.

Travel:
You may be required to travel for up to 5% of your time.
In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, ESPP, and 401k match. We also provide 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, and a winter company shutdown.

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.

Equal Opportunity 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.

Vaccination requirement:

Following extensive monitoring, research, consideration of business implications, and advice from internal and external experts, Crinetics requires that all employees and contractors be fully vaccinated and have received the COVID-19 vaccines as a condition of employment. “Full vaccination” is defined as two weeks after both doses of a two-dose vaccine or two weeks since a single-dose vaccine has been administered. Anyone unable to be vaccinated, either because of a sincerely held religious belief or a medical condition or disability that prevents them from being vaccinated, can request a reasonable accommodation.