Senior Regulatory Writer – Clinical; Remote

Job Description:
Senior Regulatory Writer – Clinical (Remote)

At Facet, our mission is to make life sciences dreams a reality. We are regulatory and development leaders with a passion for designing and implementing innovative strategies and tactical solutions to advance great science. Our experience enables us to deliver streamlined and innovative solutions for small organizations to help expedite products to and through FDA to patients in need.

For over 10 years, Facet has leveraged our strong scientific, development, and regulatory expertise to help small organizations reach successful outcomes, from product concept to commercialization. We love to tell a good story and great science makes for a great story!

If you love regulatory writing, Facet may be a great fit for you. Many writers want to go beyond writing and make their mark in the regulatory affairs space as well. If this is you, Facet may be the perfect place to take your career to the next level. Come help us create great success stories – both for our customers and for you!

The Senior Regulatory Writer is focused on helping emerging life science companies advance their drug, biologic, device, or combination product through regulated development. This involves the planning, preparation, and finalization of clinical documents.

To be successful, the Senior Regulatory Writer must be able to work independently and will be accountable for direct interactions with Facet customers. The Senior Regulatory Writer may also interact with physicians, payers, patients, and government agencies. Responsibilities include leading data review, cross-functional planning, document review meetings, and adhering to document timelines. In addition, Facet strongly supports and expects the Senior Regulatory Writer to be an active participant in service to the industry (e.g., industry memberships, conference presentations, or publications).

Success also requires strong interpersonal skills (e.g., good negotiation, conflict management), a willingness to ferret out information, manage constructive criticism proficiently, and an ability to analyze complex issues and distill them into simple yet compelling messaging.

This is a remote (work from home) full-time position. To qualify, applicants must be legally authorized to work in the United States, and should not require, now or in the future, sponsorship for employment visa status.

• Serve as lead for multidisciplinary medical writing projects
• Prepare, author, and finalize regulatory submission documents for IND, NDA/BLA, DMF, 510k, and/or PMAs, such as:
  • Clinical protocol and amendments, study reports, patient narratives, safety reports, and ICFs
  • Clinical portions of IBs, GIPs, ARs, and DSURs
  • ISE, ISS, SCE, and SCS
  • Clinical responses to FDA IRs
  • HF clinical study protocols and reports
  • Clinical components of FDA meeting requests and background packages
  • ODR, BTD, rare pediatric/rare tropical disease designation requests, IPSP, and general waiver requests
• Perform standard editorial and QC functions (proofread copy for spelling/grammatical errors; fact checking scientific content; identify and correct plagiarism)
• Maintain timelines and work within the assigned contract budget for writing assignments
• Be familiar and work in accordance with US Federal Regulations, Good Clinical Practices and ICH guidelines, and Facet SOPs
• Contribute to the development and maintenance of Facet and departmental working practices and procedure.

• Bachelor of Sciences required. Advanced degree in a scientific discipline (e.g., MS, Ph.D., PharmD, MD) strongly preferred
• At least 3 years of experience in a lead regulatory writing role required
• At least 5 years of relevant pharmaceutical/scientific…