Writing Jobs in Hackettstown, NJ (NOW HIRING)

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.

• 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.

• This position requires up to 10% of travel
• Manage a team of 3 direct reports

• 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

• 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.