Senior Medical Writer

Categories: Regulatory
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 Medical Writer will be responsible for clinical/regulatory documents (eg, clinical protocols, investigator’s brochures, clinical study reports, annual reports, regulatory briefing documents/dossiers and meeting requests, and IND/NDA/BLA summary modules). This position will be the lead medical writer on programs varying in stages of development.

Essential Job Functions and Responsibilities: 

  • Write clinical protocols, clinical study reports, investigator’s brochures, annual reports, IND summary sections, IMPDs, and NDA/BLA summary modules, and other regulatory documents
  • Develop and maintain timelines for document generation, revision, and completion in collaboration with cross-functional study team members
  • Assist in the development and maintenance of SOPs and writing tools, such as templates and style manuals
  • Provide training on medical writing templates, quality control (QC) and quality assurance (QA) procedures, SOPs, and processes within the department and across departments
  • Contribute to the development of electronic document systems and tools
  • Provide project teams with guidance and problem resolution related to document generation
  • Ensure writing meets scientific and Regulatory standards and meets objectives
  • Lead document writing and review process
  • Coordinate and manage review cycles to triage, incorporate, and resolve team comments, and lead discussions on document revision and finalization
  • Manage outsourced writing projects
  • Provide quality control support to other document authors (review of various regulatory documents)
  • Incorporate comments and QC/QA findings and resolve queries to present a ‘finished’ final document/submission
  • Take initiative to solve problems exercising sound judgment and appropriate flexibility within a dynamic environment
  • Undertake research in the therapeutic area to allow effective writing
  • Take on other duties as assigned
Education and Experience:
  • Advanced life sciences degree preferred, eg, MS, RN, RPh, PhD. A Bachelor’s degree required. A minimum of 5 years regulatory medical writing experience in the biotech/pharmaceutical industry. An equivalent combination of experience and education may be considered.
  • Experience producing INDs/BLAs/NDAs/MAAs, and familiarity with eCTD structure and granularity requirements
  • Experience with clinical protocols and clinical study reports including assembly of all CSR ICH appendices
  • Experience with electronic document control and management system
  • Familiarity with statistical analysis
  • Working knowledge of good publication practice and regulations relevant to medical writing
  • Working knowledge of GCP, GLP, GMP, and ICH guidelines and related FDA/EMA guidances on submission elements and integrated summaries of safety and efficacy
Required:
  • Excellent ability to write clear, grammatically-correct technical, medical, and scientific text at a level appropriate for the audience and project with careful attention to detail and accuracy
  • Ability to learn new therapy areas quickly and comprehensively
  • Ability to write or review for accuracy of scientific and regulatory data and references
  • Strong project management skills with ability to manage and prioritize multiple projects while adhering to overlapping timelines
  • Ability to assess workload and suggest prioritization to senior staff
  • Demonstrate ability for independent thought
  • Desire to work in a collaborative team setting
  • Ability to communicate fluently and effectively in written and verbal English
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:  $163,078- $172,727

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. 

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