We're looking for a Director of Medical and Scientific Writing (Publications and Regulatory Writing teams) to help us accomplish our mission to improve lives by learning from the experience of every patient with cancer. 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 will lead Flatiron Health’s Medical and Scientific Writing function which consists of the Scientific Publications team and the Clinical and Regulatory (Medical) Writing team. This position reports into the Head of Strategic Affairs. As Director, you will work closely with scientists and business leaders to develop and implement a strategic vision across Flatiron Health for scientific publications and for medical writing. In this role, you will serve as a company-wide steward of high-quality scientific publications and medical writing, a driver of fit-for-purpose publication and medical writing support, and a subject matter expert resource for cross-functional colleagues.
Scientific peer-reviewed publications at Flatiron Health span from clinical applications of retrospective real-world data and real-world evidence methods to prospective clinical studies conducted by our internal teams using Flatiron Health’s electronic health record-derived real world database. In addition to Flatiron Health employees, authorship teams for peer-reviewed publications may include investigators from regulatory bodies, academic institutions, and life-science partners. The Clinical and Regulatory Writing team closely collaborates with internal experts and its scope includes writing research protocols, creating research templates such as for statistical analysis plans, managing oversight by a central Institutional Review Board, and developing Briefing Documents / appendices in support of regulatory (e.g., FDA) filings. The Publications team and the Director, Clinical and Regulatory Writing report into this role.
In this role, you will
- Create, lead, and execute a plan to achieve Flatiron Health’s scientific publications and medical writing strategy.
- Lead and manage a dynamic team of 4 medical writing professionals
- Directly oversee, contribute to, and/or provide project management for 50 to 75+ peer-reviewed publications with Flatiron Health co-authors (manuscripts, abstracts, and conference posters) and facilitate review of 400+ externally authored (led by our life science and academic partners) publications that use Flatiron Health data annually, with the assistance of two publication professionals
- Interact with and support research teams from a range of scientific disciplines (e,g. epidemiology, biostatistics, health equity research, retrospective data methods and prospective studies)
- Engage with stakeholders in Regulatory Affairs, Privacy, Legal, Research Marketing, Life Science Partnerships, etc.
- Support and mentor team members to enhance capabilities, expand capacity and optimize processes for complex outputs in an evolving company.
- Serve as Flatiron Health’s internal and external Publications and Medical Writing leader
- Work with the Publication Governance Committee (composed of senior cross-functional scientific and business leaders) to set Flatiron Health’s annual health technology and scientific publication strategy.
- Effectively drive cross-functional alignment on the vision and scope of the Publications and Medical Writing teams in a growing tech-based company with evolving and varied needs (e.g. retrospective and prospective research, clinical and methodological research, US-based and international research, etc.)
- Promote research internally and externally through collaboration with cross-functional teams to create and implement strategy
- Develop, maintain, and assess rigorous publication and writing metrics, and present recommendations to cross-functional stakeholders.
- Cultivate relationships with scientific journal editors and pitch relevant content
- Ensure high-quality scientific writing, including adherence to all relevant research publication, regulatory, and authorship standards (e,g. ICMJE, GPP3, GPP, ICH E3, ICH E6, ICH E9 and GCP) and compliance with internal processes
- Develop budgets and manage resources to optimize quality, efficiency, and alignment with Flatiron Health’s scientific objectives.
- Individual writing contributions anticipated for high-priority/complex publications.
In addition, you will have the opportunity to collaborate with Flatiron Health teams leading engagement with external life-science leaders, regulators, and academic scientists in the US and internationally, learn from real-world data experts globally, and partner with key engineering, product, and data platform teams. You will join a supportive, highly-collaborative multidisciplinary environment committed to your success and to high-quality scientific publications.
Who You Are
You're an experienced medical writing leader who is a nimble thinker, goal-oriented, able to provide a strategic vision for the team and deliver in an evolving arena. You have 10-15+ years of experience in medical and/or scientific publication writing and management, including drafting, copyediting, literature review, leading, process development and strategy setting. You're excited by the prospect of rolling up your sleeves to tackle meaningful questions 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.
- Strong written and oral communication with direct scientific writing experience (e.g. manuscripts, abstracts, posters, regulatory documents)
- Familiarity with observational data, health outcomes/health services research, and/or methodological/discovery research concepts
- Broad understanding of and strategic experience in the research publication space ( e.g. methodologic and clinical journals and conferences).
- Strong knowledge of research and scientific writing standards (e.g. AMA)
- Familiarity with clinical and regulatory writing concepts and requirements, including protocols, SAPs, Briefing Documents and accompanying Appendices
- Experience managing and leading complex author teams, including contractors and external collaborators, whose research supports a broad range of business lines
- Experience developing/managing budgets, including external spending
- Knowledge of oncology and experience working in business or technology space
- Experience with scientific publication authorship teams that include investigators from a variety of disciplines (e.g. medical, epidemiology, and biostatistics), affiliations (e.g. industry, academic, pharmaceutical, regulatory) and roles (i.e. internal or external to the writer’s organization)