DePuy Synthes, part of the Johnson & Johnson MedTech companies, is recruiting for a Staff Clinical Research Scientist . The preferred location for this role is Warsaw, IN or Leeds, United Kingdom however candidates within a commutable distance of West Chester, PA will also be considered . The role will work a Flex/Hybrid schedule with 3 days per week on-site. Relocation assistance is available to qualified candidates.
About Johnson & Johnson

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 https://www.jnj.com/. On behalf of the MedTech Group, this clinical research professional will be responsible to develop clinical evidence generation strategies (EGS) across assigned New Product Development (NPD) and Life-Cycle Management (LCM) projects.
Key Responsibilities :

• Contribute to the development and deliver appropriate Global EGS to support NPD and LCM within the assigned platforms, with collaborative relationships with all relevant Clinical R&D partners and cross-functional partners (R&D, Global Strategic Marketing, Medical Affairs, Regulatory Affairs, Health Economics and Market Access), and ensure input and strong alignment from key regional leads.

• Develop and draft clinical trial protocols, informed consents, investigator brochures, and other study materials with minimal direction.

• Plan for study budgets and collaborate with Clinical Operations to lead the development of Investigator agreements and site contracts within fair market value (FMV), vendor agreements, payments, and financial disclosures.

• Responsible for delivery of assigned clinical programs, through effective partnership with the Clinical Operations and Biostats / Data Management teams, to enable optimized engagement leading to delivery of clinical project commitments (deliver on time, within budget and in compliance with regulations and operating procedures).

• Develop positive relationships with the study core team and others to ensure study progress for assigned projects and that issues are identified and communicated to leaders.

• Support clinical scientific discussions with regulatory agencies / notified bodies to drive support of the clinical and regulatory strategy, including proposed clinical investigations; review process of clinical evidence generated for marketing authorization, line extensions, etc., including during sponsor regulatory inspections.

• Contribute to appropriate interpretation and dissemination of all evidence generated, including abstracts, manuscripts, CSRs, and use of clinical data/evidence for market access and reimbursement. Draft study reports with minimal direction for assigned studies to include any annual reports, study close out reports as well as clinical sections for regulatory documents such as Clinical Evaluation Reports.

• Foster strong relationships with key investigators to deliver evidence.

• Keep management informed of key developments and issues that impact clinical strategy and portfolio management, while maintaining a strong understanding of the pipeline, product portfolio and business needs.