Director, Medical Writing (Regulatory)
Flatiron Health is a healthcare technology and services company focused on accelerating cancer research and improving patient care. Our platform enables cancer researchers and care providers to learn from the experience of every patient. We believe that existing clinical research paradigms are ill-equipped to answer the research questions that face drug developers, academic researchers, and regulators in the oncology space today.
Flatiron Research is focused on innovating in the real-world evidence (RWE) and clinical trials space. Our technology-first approach has allowed us to build RWE data sets with higher quality, accuracy, recency, and scale than any other cancer data that is available. We have active partnerships with top-tier academic medical centers, the top 15 oncology biopharma companies, the FDA, and the NCI, all focused on using data to accelerate the research and treatment of cancer.
We're looking for an experienced clinical regulatory medical writer, interested in innovation and looking to be a key member of research teams in a fast-paced, mission-driven environment. Here's what you need to know about the role, our team and why Flatiron Health is the right next step in your career.
What You'll Do
In this role, you'll spearhead the development of our new medical writing function and serve as the senior medical writer for research projects with a clinical study or regulatory focus. In this role, you will start as an individual contributor to lay the groundwork for our medical writing capabilities across the organization, working with cross-functional teams to ensure Flatiron delivers high quality documents to our life sciences partners and other strategic collaborators as needed. In addition, you'll:
- Build and implement Flatiron’s medical writing framework, including appropriate templates and procedures, thus providing direction to our Research teams re: AMWA GCP, ICH-E3, and other industry standards, development or modification of Standard Operating Procedures to meet life science and/or health authority standards is anticipated.
- Maintain familiarity with evolving industry practices and regulatory requirements and guidelines that affect medical writing.
- Assess relevant existing and proposed process flows across our Research teams and make recommendations to leadership about how to ensure scaling and efficiency of our regulatory writing capabilities and worksteams.
- Act as clinical writing lead for relevant research projects, managing and coordinating medical writing activities and information flow across different functions within study teams with minimal to no supervision.
- Develop or support a variety of document types such as:
- Protocols, protocol amendments, statistical analysis plans
- Study reports and executive summaries
- Regulatory submission packages: integrated summary reports, NDA and/or (e)CTD submissions
- Perform background literature research and write, edit, and coordinate content for clinical/regulatory documents.
- Be a key contact for research teams throughout the process of reporting results.
- Identify questions and issues during writing, proposing solutions and/or escalating as appropriate.
- Interact with team members in clinical data, quantitative sciences, research oncology, integrated quality management, regulatory affairs, and other departments as needed to produce writing deliverables.
- Interact with scientific publication team members to coordinate internal and external research reporting.
- Review documents generated by teams, providing review comments on draft and final documents as needed.
- Complete assignments on time, remain aware of project management and timeline considerations during the writing process.
In this role, you will get the opportunity to work with a wide range of cross functional teams such as Regulatory Affairs, Integrated Quality Management, Life Sciences Partnerships, Research Oncology, Product, Research Operations, and Quantitative Sciences.
Who You Are
You're a regulatory medical writing professional with 7 or more years of medical writing experience within the biopharma industry, with experience ideally across all aspects of regulatory documents including but not limited to investigational new drug applications, clinical study reports, regulatory briefing books, new drug/biologic license applications, and other documents such as orphan drug applications, breakthrough therapy applications, etc. Ex-US regulatory submission expertise is beneficial but not required. You're excited by the prospect of rolling up your sleeves to tackle meaningful problems each and every day. You’re a kind, passionate and collaborative problem-solver who seeks and gives candid feedback, and values the chance to make an important impact.
- You have a Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English or Communications, preferred) with relevant scientific and/or medical knowledge and expertise. Relevant advanced degrees such as a PharmD, PhD, or MPH are desired but not required.
- You have a command of English grammar and FDA and ICH regulations and guidelines as well as a familiarity with AMA style guide.
- You demonstrate understanding of clinical research, the drug development process, and applicable regulatory guidelines. You maintain a familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.
- You demonstrate independence and ability to influence in a cross functional environment with effective interpersonal skills to ensure a team-oriented problem solving approach.
- You have effective communication skills (presentation and written) and attention to detail.
- You are willing to tackle hands-on work and to lay the groundwork for a regulatory writing capability in Flatiron Health.
- You have the interest, aptitude and ideally experience in building and managing a professional team of colleagues both inside and outside of your organization.
- Experience writing for Phase IV or outcomes research studies.
Why You Should Join Our Team
A career at Flatiron is a chance to work with everyone involved in the future of cancer care and research—all under one roof. Research oncologists, data scientists, including epidemiologists and biostatisticians, designers, clinicians, software engineers and other subject matter experts contributing to our research projects, and many more all work together to improve cancer care and accelerate research.
You'll also find a culture of continuous learning, broad and inclusive employee support offerings, and a commitment to supporting our team members in all aspects of their lives—at home, at work and everywhere in between. We offer:
- Flatiron University training curriculum which includes presentation skills, meeting mastery, coding languages and more
- Career coaching opportunities
- Hackathons for all employees (not just our engineers!)
- Professional development benefit for attending conferences, industry events and external courses
- Work/life autonomy via flexible work hours and flexible paid time off
- Generous parental leave (16 weeks for either parent)
- Back-up child care
- Flatiron-sponsored fitness classes
Flatiron Health is proud to be an Equal Employment Opportunity employer.
We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.