Manager, Regulatory Medical Writing X-TA

At Johnson & Johnson,?we believe health is everything. Our strength in healthcare innovation empowers us to build a?world where complex diseases are prevented, treated, and cured,?where treatments are smarter and less invasive, and?solutions are personal.?Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.?Learn more at www.jnj.com. Summary: The Manager, Regulatory Medical Writing X-TA will be responsible for the development of high-quality regulatory documents, including but not limited to clinical summaries, protocols, investigator brochures, and submission documents (e.g., Module 2) for regulatory submissions to health authorities (e.g., FDA, EMA, PMDA) to support product development and/or lifecycle management of products. The Manager will be expected to effectively manage medical writing projects, including scope, budget, and timeline. The Manager will also be expected to provide guidance to medical writers, including training and mentoring, and ensure that all documents are compliant with relevant regulations and guidelines. The Manager will collaborate with cross-functional teams, including but not limited to Clinical Development, Regulatory Affairs, and Global Medical Affairs, to ensure timely and successful submissions. The Manager may also be responsible for managing external vendors. Responsibilities: * Lead the development of high-quality regulatory documents for submission to health authorities. * Manage medical writing projects, including scope, budget, and timeline. * Provide guidance and mentoring to medical writers. * Ensure that all documents are compliant with relevant regulations and guidelines. * Collaborate with cross-functional teams to ensure timely and successful submissions. * Manage external vendors as needed. * Effectively communicate and coordinate with stakeholders at all levels of the organization. * Manage competing priorities and complex tasks with minimal supervision. * Identify and implement process improvements. * Ensure documents are in compliance with relevant regulations and guidance and Company SOPs and policies. * Participate in departmental and/or cross-functional project teams. * Perform other related duties as assigned. Qualifications * A minimum of a Bachelor's degree (advanced degree preferred) in a scientific discipline (e.g., Biology, Chemistry, Pharmacy) is required. * A minimum of 5 years of relevant experience in medical writing is required. * Strong understanding of regulatory requirements and guidelines (e.g., FDA, EMA, PMDA) is required. * Experience with submission documents is required. * Excellent written and verbal communication skills are required. * Excellent project management and organizational skills are required. * Experience with managing external vendors is preferred. * Ability to work independently and as part of a team is required. * Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint) is required. * Experience with electronic document management systems (EDMS) is preferred. * Experience with the drug development process is preferred. * Experience with the development of clinical trial protocols is preferred. Johnson & Johnson is an Affirmative Action and Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability. For more information on how we support our employees, see https://careers.jnj.com/employee-benefits.