- Entry level
- No Education
- Salary to negotiate
DePuy Synthes Companies of Johnson & Johnson is recruiting for a Manager Technical Writing, CER, Medical Operations with primary location in Warsaw, IN but consideration can be given to other field-based locations (Raynham, MA, Somerville, NJ, Cincinnati, OH, West Chester, PA, Irvine, CA). This position may require up to 15% travel.
DePuy Synthes Companies of Johnson & Johnson is the largest, most innovative and comprehensive orthopaedic and neurological business in the world. DePuy Synthes Companies will offer an unparalleled breadth and depth of products, services and programs in the areas of joint reconstruction, trauma, spine, sports medicine, neurological, craniomaxillofacial, power tools and biomaterials. Building on the legacy and strengths of two great companies, we have created one organization with a focus on activating insights to develop innovative, comprehensive healthcare solutions.
The Manager Technical Writing, CER, Medical Operations provides leadership, motivation, and strategic direction for the general medical writing activities for the generation of Clinical Evaluation Reports (CER) and Summary of Clinical Safety and Performance (SSCP) Reports for assigned therapeutic area within J&J Global R&D Medical Device sector.
Under limited supervision and in accordance with all applicable federal, state and local laws/regulations and Corporate Johnson & Johnson, procedures and guidelines, this position:
• Provides management leadership to a team preparing Clinical Evaluation Reports.
• Provides strategic oversight and guidance to all CER 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 operating company CER timelines are met and practices are being consistently deployed across the global organization
• In conjunction with the Director and Sr. Manager Shared Services, designs, develops and leads workshops to define processes globally 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 CERs and SSCPs 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 Medical Operations budget pertaining to the businesses within his/her scope of responsibility
• Responsible for communicating business related issues or opportunities to next management level
• 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
• A Bachelor’s Degree or BSN is required; Advanced degree is preferred.
• A minimum of 5 years of related job experience is required.
• Experience within the medical device industry and knowledge of clinical evaluation report regulatory requirements, evidence generation, and 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 is required.
• Strong oral communication, interpersonal skills, presentation, project management and prioritization skills is required.
Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
North America-United States-Ohio-Cincinnati, North America-United States-Pennsylvania-West
About the company
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