Senior Medical Writer

Job Description: Senior Regulatory Writer (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!

Role description:

The Senior Regulatory Writer is focused on helping emerging life science companies advance their drug, biologic, device, or combination products through regulated development.  This involves the planning, preparation, and finalization of nonclinical, CMC, clinical and/or commercial 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, and document review meetings, and 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.

Key Responsibilities (based on subject matter expertise):

• 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:
  • Nonclinical protocols, study reports, nonclinical introductions, nonclinical written and tabulated summaries, nonclinical responses to FDA information requests
  • Clinical protocol, protocol amendments, study reports, patient narratives, IBs, ICFs, GIPs, ISE, ISS, SCE, SCS, safety reports, ARs, DSURs, and responses to FDA IRs
  • QOS, DS, DP, stability protocols, appendices
  • HF study protocols and reports, risk matrices, IFU
  • FDA meeting requests, background packages, ODR, BTD, rare pediatric/rare tropical disease designation requests, responses to FDA IR, IPSP
• Prepare commercial documentation such as product value propositions, value dossier preparations, payer communications, early-stage evidence generation plans, treatment comparisons, burden of illness / patient experience descriptions, market landscape analysis, and competitive landscape mapping
• Perform standard QC functions (proofread copy for spelling/grammatical errors and fact checking of scientific content)
• 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
• Maintain project budgets
• 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) strongly preferred
• At least 3 years of experience in a lead regulatory writing role required
• At least 5 years of relevant pharmaceutical/scientific experience required
• Ability to analyze complex information (i.e., trial designs, statistical methods, trial results, medical information)
• Proficient in evaluating and accurately portraying conflicting information
• Ability to distill complex information into clear, compelling, data-supported messaging
• Strong organizational skills and attention to detail
• Strong time management skills
• Expert in MS Word, Excel and Power Point
• 21 CFR Part 11 document management experience desirable

Benefits and Compensation:

We are a small company with big company benefits.  Providing great benefits to keep our Facet colleagues healthy and happy is a core value for us.  We provide our team members with top-notch benefits:

• health insurance plan
• supplemental insurance
• dental insurance
• life insurance
• short- and long-term disability insurance
• 401K program
• Several bonus programs
• Company-supported, required annual training
• Flexible work environment
• Unlimited sick and vacation

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