Job Description: Strategic Regulatory Writer (Remote and Full Time)

At Facet, our mission is to make life sciences dreams a reality. We are regulatory and development leaders with a passion for helping small organizations expedite innovative products to and through FDA to patients in need. We are a small company with big company benefits, including health, dental, life, supplemental, and disability insurance; a 401K program; bonus programs; company-supported annual training; a flexible work environment; and unlimited sick and vacation time.

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!

Role description:

The Strategic Regulatory Writer is focused on helping emerging life science companies advance their drug, biologic, device, or combination product through regulated development by planning, preparing, and finalizing clinical, nonclinical, and/or CMC documents. The role works independently and collaborates closely with fellow writers, regulatory strategists, document specialists, and clients. Responsibilities include leading data review, cross-functional planning, document review meetings, and adhering to document timelines. Success requires strong interpersonal skills, 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. 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.

Key Responsibilities:

• Serve as lead for multidisciplinary medical writing projects.
• Prepare, author, and finalize regulatory submission documents for IND, NDA/BLA, DMF, 510k, and/or PMAs (based on your subject matter expertise – clinical, nonclinical, CMC).
• Perform standard editorial and QC functions (proofread copy for spelling/grammatical errors; fact check scientific content; identify and correct plagiarism).
• Maintain timelines and work within the assigned contract budget for writing assignments.
• Be familiar with 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.

Experience and Skills Desired:

• Bachelor of Sciences required. Advanced degree in a scientific discipline (e.g., MS, Ph.D., PharmD, MD) and at least 5 years of relevant pharmaceutical/scientific experience strongly preferred.
• At least 2 years of experience in a regulatory writing role required.
• At least 1 year of experience independently leading regulatory document writing projects required.
• Experience with IND, NDA, or BLA submission work, as lead or part of writing team.
• Ability to analyze complex information (i.e., trial designs, statistical methods, trial results, medical information) and proficient in evaluating and accurately portraying conflicting information.
• Ability to distill complex information into clear, compelling, data-supported messaging.
• Strong organizational and time management skills, attention to detail.
• Expert in MS Word, Excel, and Power Point.
• Experience with regulatory document management systems (e.g., Veeva Vault).

Salary range: $120,000 – $180,000 USD, depending on qualifications and experience.

Have questions? Contact Eva Raspor at eva.raspor@facetls.com.