Senior Medical Writer
Categories: Regulatory
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. 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 Senior Medical Writer will be responsible for writing clinical and regulatory documents such as clinical protocols, clinical study reports, investigator’s brochures, regulatory meeting requests and briefing documents, and summary modules for INDs and NDAs/BLAs. This position will be the lead medical writer for an early-stage program and will also assist in supporting programs in later stages of development.
Essential Job Functions and Responsibilities:
These may include but are not limited to:
- Write and manage review and approval of clinical protocols, clinical study reports, investigator’s brochures, and other regulatory documents as requested
- Develop document writing, review, and approval timelines in collaboration with cross-functional team members to meet company goals and proactively manage document development per the set timelines
- Coordinate and/or manage review cycles to triage, incorporate, and resolve team comments, and lead discussion on document revision and finalization for both internally written and outsourced documents
- Ability to write clear, scientifically accurate text at a level appropriate to the audience and the project with careful attention to detail
- Assist in the development of medical writing infrastructure, such as templates, SOPs, and style manuals
- Take the initiative to solve problems exercising sound judgment and appropriate flexibility within a dynamic environment
- Ability to quickly learn disease states to meet medical writing resource needs across multiple programs
Education and Experience:
Required:
- Bachelor’s degree in life sciences with a minimum of 5 years regulatory medical writing experience in the biotech/pharmaceutical industry (3 years with advanced degree)
- Experience writing clinical protocols, clinical study reports, and investigator’s brochures
- Ability to manage/work on multiple writing projects at once while balancing overlapping timelines
- Demonstrated ability to collaborate across multiple scientific and operational functions to achieve timely document completion
- Knowledge of regulations and guidance relevant to medical writing (eg, GCP, ICH guidelines, and FDA/EMA guidance)
- Understanding of statistical analysis as it pertains to clinical trials
- Experience using an electronic document management system as the primary tool to complete document generation, writing, review, and approval
- Excellent communication and interpersonal skills with a service-oriented mindset
- Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally
Preferred:
- Advanced degree in life sciences
- Experience with writing summary and overview sections of INDs/BLAs/NDAs/MAAs and an understanding of CTD structure and granularity requirements
- Experience developing medical writing infrastructure such as templates, SOPs, and style manuals
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.
The Anticipated Base Salary Range: $91,000-$121,000
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.