Sr. Manager, Medical Writing

Job description

Terumo Medical Corporation (TMC) develops, manufactures, and markets a complete, solutions-based portfolio of high-quality medical devices used in a broad range of applications for numerous areas of the healthcare industry. TMC places a premium on providing customers with world-class products, training and education programs that drive clear economic value, better clinical outcomes and improved quality of life for patients. TMC is part of Tokyo-based Terumo Corporation; one of the world’s leading medical device manufacturers with $6+ billion in sales, 30,000+ employees worldwide and operations in more than 160 nations. Terumo Medical Corporation is comprised of two strategic business divisions: Terumo Interventional Systems and Terumo Medical Products. We believe that the future is bright for everyone at Terumo. We work with the future in mind to generate lasting change, create a bigger impact and produce greater outcomes for today, and for decades to come. At Terumo we believe in the power of personal growth and will encourage you to get in the driver's seat - progressing in the direction you want to go by deepening your skills throughout your career. We want you to be bold, think outside the box, experiment, innovate and deliver what's next for quality healthcare. You will be part of a collaborative, respectful and resilient team of associates and leaders around the world, working together as partners to achieve more than you thought possible, providing real-world, impactful solutions for patients. Join us and help shape wherever we go next! Advancing healthcare with heart Job Summary Sr. Manager Medical Writing, manages and oversees the work of medical writing teams to support clinical and regulatory submissions (e.g., clinical evaluation reports, clinical study reports,) and product development. This role partners with Engineering and R&D, Clinical Affairs, Professional & Clinical Education, Regulatory Affairs, Quality Systems, Marketing, Sales as well as external stakeholders, to include FDA, NB, PMDA, KOL, HCP, IRB and publishers. The role reports directly to the Senior Medical Director, Scientific Data & Communications. Job Details/Responsibilities Lead, mentor, and develop a team of medical writers responsible for clinical evaluation, scientific communication, and regulatory documentation. Oversee workload allocation, project prioritization, and timely delivery of high‑quality documents; and lead talent development in alignment with growth strategies of the department. 40% of role. Provide technical guidance, writing expertise, and scientific oversight to ensure consistency, accuracy, and compliance with applicable regulations and internal standards. Develop and maintain SOPs, work instructions, and best practices related to medical writing. Serve as subject‑matter expert in medical writing standards, expectations of regulatory bodies, and scientific communication. 20% of role. Review and approve the team outputs including regulatory documents / scientific communication / clinical research related documents. 20% of role. Assure Quality Oversight & Regulatory Compliance. Oversee literature review methodologies, literature database management practices, and interpretation of scientific evidence. 10% of role. Build and manage internal partnerships with PACE, Clinical Operations, Regulatory Affairs, Quality System and Marketing R&D and Engineering. 10% of role. Working Conditions/Physical Requirements This position requires up to 10% of travel Manage a team of 3 direct reports Knowledge, Skills and Abilities (KSA) Strong leadership in project and team management, including coaching and performance oversight. Excellent organizational and time management skills Expertise in medical writing processes, regulatory requirements (FDA, EU MDR), with GCP, and ICH guidelines Ability to adapt to changing priorities Knowledge of biomedical statistics, clinical literature review Highly proficient in using Microsoft Office applications (Word, Excel, PowerPoint) and EndNote Expertise in conducting focused literature searches on PubMed, Embase, MedLine or other similar medical literature databases Knowledge and understanding of PICO methodology Ability to function in a self-directed manner with a high degree of independence Strong verbal, written, and interpersonal communication skills Ability to persuasively influence external medical professionals Effective analytical and problem-solving skills Excellent interpersonal and effective leadership, verbal and written communication skills and effectively work across departments with diverse needs Qualifications/ Background Experiences Advance Degree ((Ph.D., MD, Sc.D, MA/MS or MPH) in a medical/biomedical/scientific discipline with a minimum of 5 years of experience in medical writing of regulatory documentation (clinical research documentation is optional) OR Bachelor’s Degree, preferably in life sciences with 10 years of relevant work experience; OR equivalent combination of education, training and relevant experience. Demonstrated relevant track record in people management how many years? Experience in medical or scientific writing and creating content for scientific presentations Demonstrated experience in the development of regulatory/clinical submissions, preferably as a medical writer for pharmaceutical, CRO, or medical device clients, a strong plus. Experience with Class III devices and CER development under MDR preferred It is Terumo’s policy to provide equal employment opportunity to all its employees and applicants for employment regardless of their race, creed, color, national origin, age, ancestry, nationality, marital or domestic partnership or civil union status, sex, pregnancy, gender identity or expression, disability status, liability for military service, protected veteran status, sexual orientation, atypical cellular or blood trait, genetic information (including the refusal to submit to genetic testing), or any other category protected by law. As a Company, we value diversity of background and opinion, and prohibit discrimination or harassment on the basis of any legally protected class in the areas of hiring, recruitment, promotion, transfer, demotion, training, compensation, pay, fringe benefits, layoff, termination or any other terms and conditions of employment. Final compensation packages may be higher or lower than what is listed, and will ultimately depend on factors including relevant experience, internal equity, skillset, knowledge, geography, education, business needs and market demand. We provide competitive and comprehensive benefit options which include: annual bonus, paid vacation, paid holidays, health, dental and vision benefits, 401(k), with matching contributions, tax advantage savings accounts, legal plan, voluntary life and AD&D insurance, voluntary long-term disability, short term disability, critical illness and accident insurance, parental leave, personal leave, tuition reimbursement, travel assistance, and an employee assistance program. The salary range for this role is $150,000 - $198,000 based on experience plus a 20% target bonus.