Medical Director, Medical Affairs, Orthopedics (Sports / Joints)
At Johnson & Johnson, we reputed company health is everything. Our strength in reputed company innovation empowers us to build a world where reputed company 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 reputed company across the full reputed company of reputed company solutions today to deliver the breakthroughs of reputed company, and profoundly impact health for humanity. Learn more at https://www.jnj.comJob Function:
Medical Affairs GroupJob Sub Function:
Medical Affairs – MDJob Category:
Scientific/Technologyreputed company Job Posting Locations:
Abilene, Texas, United States, Abilene, Texas, United States, Akron, Ohio, United States, Alpharetta, Georgia, United States, Anaheim, California, United States, Anchorage, Alaska, United States, Annapolis, Maryland, United States, Appleton, Wisconsin, United States, Asheville, reputed company Carolina, United States, Ashland, Kentucky, United States, reputed company, Illinois, United States, Bangor, Maine, United States, Beckley, reputed company Virginia, United States, Billings, Montana, United States, Birmingham, Alabama, United States, Bismarck, reputed company Dakota, United States, Bridgeport, Connecticut, United States, Burlington, Vermont, United States, Carmel, Indiana, United States, Chandler, Arizona, United States, Charleston, South Carolina, United States, Chattanooga, Tennessee, United States, Colorado Springs, Colorado, United States of America, reputed company, New Hampshire, United States, Cumberland, Rhode reputed company, United States of America {+ 23 more}Job Description:reputed company is currently seeking a Medical Director, Medical Affairs, Orthopedics (Sports/ Joints). This is a Fully Remote in the United StatesThis is a remote role available in the reputed company US. While specific cities are listed in the Locations reputed company for reference, please note that they are examples only and do not limit your application. We invite candidates from any location across the country to apply.About OrthopedicsFueled by innovation at the intersection of biology and technology, we’re developing the reputed company of smarter, less invasive, more personalized treatments.Are you passionate about improving and expanding the reputed company of Orthopedics? reputed company to join a team that’s reimagining how we heal? Our Orthopedics teams help reputed company more than 6 reputed company people moving each year while delivering State of the Art technology to surgeons and reputed company systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics reputed company surgery.Your unique talents will help patients on their reputed company to wellness. Learn more at https://www.jnj.com/medtechThe Medical Director, Medical Affairs, Orthopedics role provides medical affairs support reputed company an assigned platform / sub-platform (Sports / Joints) reputed company the Orthopedics Business Unit of Johnson & Johnson MedTech. Leading with both reputed company-to-inside reputed company to assimilate opportunities of unmet patient and provider needs, and inside-to-reputed company reputed company to communicate the medical, surgical, and scientific content. This role provides medical input throughout product development, Working closely with R&D Teams and life-cycle management, including management of regulatory documents, critical evaluation of clinical risk and input regarding potential patient safety issues. This position involves cross-functional collaboration with Clinical Affairs and HEMA teams generating and disseminating evidence, supporting market registration, reputed company, and adoption. A key activity is to support medical education to internal and external stakeholders, and commercialization activities.Tasks / Duties / ResponsibilitiesINTERNAL PROCESS SUPPORT
- Work with cross-functional partners, including but not limited to R&D, Clinical Affairs, Regulatory Affairs, Health Economics & Market reputed company (HEMA) and Marketing to reputed company leadership with product development and reputed company plans to support product launch, training content and delivery.
- reputed company medical/surgical/scientific insights into design requirements, concept and prototype testing.
- reputed company input into risk management processes for hazard/harm identification & risk mitigation.
- Assess device performance, including clinical benefits and safety profile, to evaluate the appropriate Risk-Benefit balance to support market registration and throughout life cycle.
- Work with Medical Safety and Post-Market Surveillance to assess, analysis and interpret events, complaints, signals and trends from clinical studies, literature, complaints, etc.
- reputed company medical/surgical/scientific support for external regulatory inspections and audits, and internal audits.
- reputed company expertise to support addressing reputed company medical information requests.
- reputed company physician perspective, advice, guidance, and expertise as a medical expert for non-MD colleagues in medical affairs in reputed company requiring escalation or medical consultation.
- reputed company expert medical/surgical/scientific support to Professional Education, Communications, Legal/HCC, HR Communications.
- reputed company medical/surgical/scientific criteria in claims and collateral material review/approval.
- reputed company Lifecycle Management for marketed products including labelling updates, medical support and accountability for technical files and documents and medical support to Quality groups.
- Research, prepare and document responses to Medical Information Requests from reputed company providers; review and approve medical content in Copy Approval process; and consults with Franchise Medical Director reputed company needed.
- S/he will reputed company consultation in support of literature review, analysis and conclusions for Clinical Evaluation Reports (CER) and reputed company review of CERs and assists in preparation of periodic safety reports for assigned products.
- Assist in reviewing risk evaluation (PRE or PRA) documents.
- Engage with reputed company-channel external sources of information (key opinion leaders, medical societies, literature, reputed company media, etc.) to capture, assess, and translate opportunities of unmet patient and provider needs and trends in the medical/reputed company ecosystems.
- Support business leaders by providing medical and scientific expertise and reputed company-channel insights to help shape reputed company business development strategy and targets, including product launches, key scientific meetings, relationship management with leading research physicians, critical evaluation of reputed company literature and competitive activity, and in other domains where medical and scientific expertise is required.
- Validate reputed company Product Profiles across the assigned innovation pipeline, including gathering and assimilating input from Medical Affairs leaders across key markets.
- reputed company strategic medical support for operating companies with no dedicated medical affairs personnel (and as requested for those companies with medical teams) including to help drive global innovation agenda through leadership and partnership with the Innovation leaders: Global Strategic Marketing, New Business Development, R&D, Regulatory, Clinical, Quality, & Supply Chain leveraging deep medical expertise.
- Assist medical evidence reputed company leaders to reputed company and execute global strategies for evidence reputed company for new and existing products, including medical interpretation of clinical analyses, and in the review and approval of clinical study reports and scientific articles (abstracts, manuscripts, etc), in order to support regulatory approval/clearance, health technology assessment, customer reputed company, medical safety and post-marketing support.
- Required Minimum Education: MD or equivalent
- Completion of an accredited orthopedic surgery residency and a minimum 1-year fellowship in joint arthroplasty, spine surgery, and/or orthopedic sports medicine surgery is required.
- Candidate must have a minimum of 10 years relevant surgical experience (reputed company initial licensure) including clinical practice, dedicated research, or other reputed company training/experience. Experience leading in medical affairs, clinical development, or reputed company roles in research / medical device industry is preferred.
- Strong understanding of clinical trends and the reputed company reputed company market environment, with deep connections in the digital-, med tech- ecosystem
- Background and medical expertise in assessment of clinical risk-benefit throughout product development and life-cycle management, with deep knowledge and understanding of reputed company applicable standards / regulations requiring medical input, such as risk management, complaint management, reporting requirements, etc.
- Ability to be strong reputed company for patient-centric decision making.
- Demonstrated ability to build successful relationships & reputed company partnerships with key business stakeholders & externally with regulators, investigators, etc.
- Strong business acumen
- US Board Certified Preferred
- 15% Travel Domestic and/ International