Manager, Scientific Operations

Johnson & Johnson is a leading global healthcare company focused on improving health and well-being worldwide. We are seeking a Manager, Medical Writer, Scientific Operations to join our MedTech team, supporting orthopedics research and development across multiple therapeutic areas. Locations Palm Beach Gardens, Florida, United States of America Raynham, Massachusetts, United States of America Warsaw, Indiana, United States of America West Chester, Pennsylvania, United States of America Job Summary The Manager, Medical Writing Scientific Operations will provide leadership, motivation, and strategic direction for scientific and medical writing activities. Key deliverables include Clinical Evaluation Reports (CER), Summary of Safety and Clinical Performance Reports (SSCP), State of the Art Reviews (SOA), and Systematic Literature Reviews (LRR) for orthopedics therapeutic areas. Responsibilities Provides strategic oversight and guidance to all SciOps resources on compliant document execution and generation Manages relationships and contracting with external vendors for generation of documents supporting these processes Develops strategic plans to ensure deliverable timelines are met and practices are consistently deployed across the organization In conjunction with the Director and, if applicable, Sr. Manager, designs, develops and leads workshops to define processes and keep abreast of regulatory requirements and industry trends, ensuring a proactive ongoing review of processes and procedures to maintain a strong regulatory profile while continually improving process efficiencies Develops and monitors metrics for all deliverables within his/her therapeutic space, providing visibility of issues and enabling corrective and preventive action to be taken as needed Accountable for assisting in the development and management of the Scientific Operations budget Supports interactions with respective Notified Bodies and regulatory agencies Supports audits and inspections pertaining to SciOps processes and deliverables Actively partners with cross-functional business partners such as Medical Directors, Post Market Surveillance, Design Quality Engineers, R&D, and Regulatory Affairs Responsible for communicating business-related issues or opportunities to next management level Responsible for following all company guidelines related to Health, Safety and Environmental practices as applicable For those who supervise or manage a staff, responsible for ensuring that subordinates follow all company guidelines related to Health, Safety and Environmental practices and that all resources needed to do so are available and in good condition, if applicable Responsible for ensuring personal and company compliance with all Federal, State, local and company regulations, policies, and procedures Performs other duties assigned as needed Qualifications BA, BS, or BSN is required; advanced degree is preferred Minimum of 5 years of related job experience Experience with spine therapeutic area preferred Experience within the medical device industry and knowledge of Clinical Evaluation Report regulatory requirements, evidence generation, literature reviews, and/or CER document creation is required Demonstrated knowledge and experience in clinical research, quality regulatory compliance, adverse event reporting is preferred Able to understand and interpret statistical results of clinical studies and understands good data management practices Strong oral communication, presentation, project management and prioritization skills Excellent interpersonal relationships 10% domestic and international travel required Preferred Skills Clinical Operations, Safety Improvements, SSCP Analysis Compensation The anticipated base pay range for this position is $117,000.00 - $201,250.00. Benefits Vacation – 120 hours per calendar year Sick time – 40 hours per calendar year; 48 hours for Colorado residents; 56 hours for Washington residents Holiday pay, including floating holidays – 13 days per calendar year Work, personal and family time – up to 40 hours per calendar year Parental leave – 480 hours within one year of birth/adoption/foster care of a child Bereavement leave – 240 hours for an immediate family member; 40 hours for an extended family member per calendar year Caregiver leave – 80 hours in a 52‑week rolling period; 10 days Volunteer leave – 32 hours per calendar year Military spouse time-off – 80 hours per calendar year Johnson & Johnson is an 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, disability, protected veteran status or any other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act. Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you have a disability and would like to request an accommodation, please email the Employee Health Support Center (View email address on click.appcast.io) or contact AskGS to be directed to your accommodation resource. #J-18808-Ljbffr Johnson & Johnson MedTech