Johnson & Johnson Careers
Associate Director, EMEA Clinical Affairs & MDR
Requisition ID: 00001D7P
DePuy Synthes Companies of Johnson & Johnson is recruiting for an Associate Director, EMEA Clinical Affairs & MDR to be based in West Chester, PA, Raynham, MA, Warsaw, IN, Leeds, England or Zuchwil, Switzerland.
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 are creating one organization that will be agile and better equipped in today's evolving health care environment. With a focus on activating insights to develop innovative, comprehensive solutions, we are inspired to advance patient care in greater ways than either company could accomplish on its own.
The Associate Director, EMEA Clinical Affairs & MDR is responsible for working with regional and franchise focused Medical, Clinical, Regulatory and Health Economics teams to develop strategies, ensure awareness and aligned implementation of EMEA evidence requirements into the global evidence generation strategy (EGS) and execution plan. The Associate Director closely collaborates with EMEA business leaders, the Franchise EGS teams, Medical Operations, Biostatistics, the EMEA Evidence Generation Council to ensure regional evidence needs and gaps are understood, reviewed and strategies are implemented for the DePuy Synthes portfolio and new product development pipeline.
- Responsible for clinical activities and complex projects for the MDR program and EMEA evidence needs
- Lead a team of clinical research professional to develop and deliver appropriate clinical evidence generation and dissemination strategies for EMEA to support products within DePuy Synthes with collobartive relationships with the global franchise and regional cross-funcational partners (Medical Affairs, Clinical Research, Regulatory, Health Economics, Marketing, R&D).
- Clinical SME in the EU Medical Device Regulation (MDR) Program.
- Represents Clinical in MDR outreach and on implementation teams; develops best practices; ensures communication within EMEA and Franchise.
- Provides strategic input and shapes clinical aspects of EU MDR for OneMD.
- Partners with clinical evaluation and PMS teams to understand and assess evidence needs, and develop clinical strategies for MDR compliance.
- Develops technical documentation including study protocols, study reports, PMCF plans, and PMCF reports.
- Collaborates with Franchise and Regional Medical and Clinical and others to ensure EMEA evidence needs are understood and input for global EGS and evidence dissemination.
- Has input into the design and executes evidence generation programs and studies in collaboration with the Franchise EGS team, Biostatistics, Data Management and Clinical Operations.
- Foster partnerships with health care systems, researchers, and/or surgeon societies to generate clinical evidence and shape clinical research.
- Partners with regulatory, regional and international RA and clinical professionals to shape the clinical RA environment, considering new and innovative ways to ensure economic, fast and compliant market access whilst considering ongoing commercial and regulatory evidence needs.
- Provides strategic clinical and scientific input for meetings with Notified bodies and authorities.
- Recruits talents and develops teams.
- Assists with market access and health economics activities by providing clinical input and expertise.
- Supports clinical review of promotional material (copy review).
- Serves as a key regional/country-level input to the innovation agenda.
- Is engaged in Environmental Scanning, New Product Development, Clinical Research and New Business Development processes.
- Provides expert clinical and scientific input.
- BS in a scientific / technical discipline is required an advanced degree is a plus
- A minimum of 8 years related scientific / technical / clinical research experience is required
- A minimum of 2 years people management experience is required
- Experience with orthopedic surgery medical devices is strongly preferred
- Good understanding of clinical research science and processes, clinical trends, and global clinical trials is required
- Knowledge of the EU MDR as it relates to pre- and post-market evidence needs is preferred
- Ability to provide scientifically strategic and scientific clinical research input is required
- Strong leadership skills to connect internally and externally to develop strong relationships in order to shape internal and external evidence strategies is required
- Ability to collaborate across different functional areas within Medical, Clinical, Regulatory, Medical Operations to ensure alignment with governance processes and to meet business objectives is preferred
- Strategic thinker able to develop and execute new evidence generation concepts is required
- Up to 20% domestic and international travel is required
- Fluency in English both written and spoken is required, other EMEA languages are a plus
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.
United States-Pennsylvania-West Chester
North America-United States-Indiana-Warsaw, Europe/Middle East/Africa-United Kingdom-England-Leeds, North America-United States-Massachusetts-Raynham, Europe/Middle East/Africa-Switzerland-Solothurn-Zuchwil
Depuy Orthopaedics. Inc. (6029)
Clinical Research non-MD