Senior Regulatory Writer - Clinical

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 clinical 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. Facet may be the perfect place to explore your regulatory writing and regulatory strategy dreams. Come help us create great success stories – both for our customers and for you! Role description: The Senior Regulatory Writer - Clinical 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). Writers who have an interest in developing or are already providing regulatory affairs guidance in addition to authoring regulatory submission documents are strongly encouraged to apply. 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: • 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 • Maintain project budgets • Contribute to the development and maintenance of Facet and departmental working practices and procedures 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 Apply tot his job