Crinetics is a pharmaceutical company based in San Diego, California that develops much-needed therapies for people with rare endocrine diseases. 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 robust pipeline across preclinical and clinical development. 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. Come join our team as we transform the lives of others.
Position Summary:
The Senior Specialist, Medical Writing and Document Quality Control (QC) will be responsible for QC review of clinical and regulatory documents (eg, clinical protocols, investigator brochures, clinical study reports, annual reports, regulatory briefing documents and meeting requests, and Common Technical Document [CTD] summary and overview sections for Investigation New Drug [IND] applications and New Drug Applications [NDAs]). This position will be responsible for verifying document text and data presentations against source documents, including programmed tables, figures, listings, clinical study documents, vendor reports, and regulatory correspondence. Qualified candidates will have experience overseeing outsourced medical writing projects and NDA experience.
Essential Job Functions and Responsibilities:
These may include but are not limited to:
- Ability to comprehend and compare scientific data presented across multiple locations in documents and identify errors or inconsistencies.
- Have extreme attention to detail, including data, writing style conventions, and formatting.
- Work in a dynamic environment and manage changing priorities across multiple projects.
- Collaborate with medical writers and other functions to resolve QC findings and move documents forward to approval with a sense of urgency.
- Take the initiative to solve problems exercising sound judgment and appropriate flexibility.
- Quickly learn disease states and therapeutic paradigm to fully support the team in a scientific writing capacity and to manage content and consistent messaging across the compound program.
- Assist in maintaining and updating the Crinetics Style Guide.
- Assist in updating and maintaining PerfectIt to match our Style Guide.
- Complete other duties as assigned.
Education and Experience:
- Bachelor’s degree in a scientific discipline required; advanced life sciences degree preferred.
- A minimum of 5 years in the biotech/pharmaceutical industry with 3 years in a quality or QC review capacity (equivalent combination of experience and education considered).
- Ability to review documents in a timely manner while paying attention to every detail.
- Understanding of the drug development process and relationship of data across documentation.
- Basic understanding of statistics as it applies to clinical trials.
- Experience using an electronic document management system as the primary tool to complete document QC.
- Experience managing/working on multiple QC projects at once while balancing overlapping timelines.
- Demonstrated ability to collaborate across multiple scientific and operational functions to achieve timely document completion.
- Knowledge of GxP and ICH guidelines and related FDA/EMA guidances on submission elements and integrated summaries of safety and efficacy.
- Excellent standard of written English, and ability to communicate fluently and effectively in written and spoken English.
- Experience contributing to process development and style standards.
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 to team members. 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: $75,000-$106,000
In addition to your base pay, our total rewards program consists of a discretionary annual target bonus, stock options, employee stock purchase program, 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 multistate 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 contingent workers 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.
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