Sr Manager Intl Clinical Research

International Evidence Generation:

• Lead support for locally relevant evidence generation projectswith global impactacross international markets, including investigator-initiated studies, collaborative research, registry analyses, and other real-world evidence activities.
• Work with investigators and internal stakeholders to shape research concepts, assess feasibility, support study set-up, and provide ongoing scientific and operational input throughtimelymeetings and written feedback.
• Support development or review of study materials, protocols, abstracts, manuscripts, presentations, and medical writing outputs whererequired.
• Ensure evidence generation activities are aligned with regional business priorities, clinical evidence gaps, compliance requirements, and available funding pathways.
• Support local evidence generation projects, including the initiation of investigator-initiated studies.
• Provide ongoing support for collaborative research projects viatimelyvideo conferences or in-person meetings with investigatorsand or providing medical writing asrequired.
• Ensure alignment with business partners with the direction and source funding asappropriate.
Clinical Support for Health Technology Assessment and Market Access:
• Provide clinical and evidence-based support for local health technology assessment submissions, reimbursement activities, value dossiers, and tender responses asrequired.
• Interpret clinical evidence in the context of local payer, provider, and customer requirements to support market access and adoption of orthopaedic technologies.
• Collaborate with regional business partners, health economics and market access colleagues, and commercial teams to ensure evidence messages areaccurate, balanced, and aligned with approved claims.
• Deliver clinical support to local health technology assessments to ensure alignment with product evidence.
• Provide clinical support to local tenders asrequired.
Dissemination and Translation of Clinical Evidence:
• Facilitate the local dissemination and translation of clinical evidence into practical resources, including white papers, evidence summaries, training materials, slide content, and customer-facing scientific support materials.
• Support evidence-focused training for regional sales and commercial teams, including delivery or support of training sessions at Leeds One and otherappropriate venues.
• Support customer-facing evidence discussions, advisory boards, and scientific exchange activities in partnership with medical affairs, professional education, and commercial stakeholders.
• Support publication and presentation activities at relevant regional and international conferences, including congress abstract development, presentation preparation, and congress evidence planning.
• Facilitate the local dissemination of clinical evidence, including the development of white papers and training materials to aid sales teams in theutilizationof evidence assets.
• Support local sales training at Leeds One focused on evidence outputs.
• Support meetings with EMEA customers on evidence.
• Attend and support publication/presentationsat local conferences (e.g. EKS,ESSKA,EFORT, BOA etc.)
Clinical Regulatory Strategy Consultation:
• Consult on clinical regulatory strategywith Global Clinical teamfor new product introductions and post-market evidence requirements, including alignment with EU MDR and other applicable international regulatory expectations.
• Consulton equivalence considerations, post-market clinical follow-up evidence needs, andminimumclinical datasetsrequiredto support product approval, maintenance, and market access.
• Partner with global clinical, regulatory, and medical affairs teams to ensure regional evidence needs are considered within broader clinical evidence strategies.
Role Scope:
• Initial focus on Joint Reconstruction and Digital, with connectivity to Spine and TCEA.
• Potential for future expansion withadditionalresourcing., 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.
  
  Degree in life sciences, clinical research, biomedicalengineering, health sciences, or a related discipline; advanced degree preferred.
• Significant experiencein clinical research, medical device clinical evidence generation, medical affairs, regulatory clinical strategy, or a related healthcare industry role.
• Strong understanding of clinical evidence requirements for medical devices, including EU MDR, post-market clinical follow-up, real-world evidence, and health technology assessment expectations.
• Experience supporting investigator-initiated studies, collaborative research, registry analyses, clinical publications, abstracts, congress presentations, or customer-facing scientific materials.
• Ability to interpret and communicate complex clinical evidence clearly for different audiences, including internal stakeholders, commercial teams, healthcare professionals, payers, and market access partners.
• Demonstrated ability to work cross-functionally across clinical, regulatory, medical affairs, health economics, market access, legal, compliance, and commercial teams.
• Excellent written and verbal communication skills, with strong attention to scientific accuracy, compliance, and consistency of evidence messaging.
• Experience in orthopaedics, joint reconstruction, robotic-assisted surgery, digital surgery, or related medical device fields preferred.
• Comfortable working across international markets and time zones, with the ability to balance global strategy with regional and local evidence needs., Analytical Reasoning, Clinical Research and Regulations, Clinical Trials Operations, Communication, Content Evaluation, Developing Others, Digital Culture, Digital Literacy, Healthcare Trends, Inclusive Leadership, Leadership, Medical Affairs, Medical Communications, Medical Compliance, Prioritization of Tasks, Product Strategies, Scientific Research, Strategic Thinking, Team Management
  
  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 (https://www.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.