Manager, Scientific Operations

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 jnj.com As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit. Job Function: R&D Operations Job Sub Function: Clinical/Medical Operations Job Category: Professional All Job Posting 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 Description: We are searching for the best talent for a Manager Medical Writer, Scientific Operations, to join our MedTech Team. Warsaw, IN, Raynham,MA , West Chester, PA, Palm Beach Gardens, FL Fueled by innovation at the intersection of biology and technology, we’re developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding the possibilities of Orthopedics? Ready to join a team that’s reimagining how we heal? Our Orthopedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery. Your unique talents will help patients on their journey to wellness. Learn more at Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone Orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals. Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes. Purpose: The Manager, Medical Writing Scientific Operations provides leadership, motivation, and strategic direction for the general scientific and medical writing activities for the generation of Clinical Evaluation Reports (CER), Summary of Safety and Clinical Performance Reports (SSCP), State of the Art Reviews (SOA) and Systematic Literature Reviews (LRR) for their assigned therapeutic area within Orthopedics. You will be responsible for: 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 being consistently deployed across the organization In conjunction with the Director and, if applicable, Sr. Manager, designs, develops and leads workshops to define processes and keeps abreast of regulatory requirements and industry trends / practices, ensuring that a proactive ongoing review of processes and procedures is in place 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 enable 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 Clinical Evaluation Report (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 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 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 and Johnson is committed to providing an interview process that is inclusive of our applicants’ needs. If you are an individual with 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. Required Skills: Preferred Skills: Clinical Operations, Safety Improvements, SSCP Analysis The anticipated base pay range for this position is : $117,000.00 - $201,250.00 Additional Description for Pay Transparency: Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)). Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits: Vacation –120 hours per calendar year Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year 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 the 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 period10 days Volunteer Leave – 32 hours per calendar year Military Spouse Time-Off – 80 hours per calendar year For additional general information on Company benefits, please go to: - 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 Do Not Sell or Share My Personal Information Limit the Use of My Personal Information