Medical Director, Medical Affairs, Orthopedics (Sports / Joints)

Job Function:
Medical Affairs Group

Job Sub Function:
Medical Affairs - MD

Job Category:
Scientific/Technology

All 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, North Carolina, United States, Ashland, Kentucky, United States, Aurora, Illinois, United States, Bangor, Maine, United States, Beckley, West Virginia, United States, Billings, Montana, United States, Birmingham, Alabama, United States, Bismarck, North 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, Concord, New Hampshire, United States, Cumberland, Rhode Island, United States of America {+ 23 more}

Job Description:

Johnson and Johnson is currently seeking a Medical Director, Medical Affairs, Orthopedics (Sports/ Joints). This is a Fully Remote in the United States

This is a remote role available in the Continental US. While specific cities are listed in the Locations section 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 Orthopedics

Fueled by innovation at the intersection of biology and technology, we're developing the next generation of smarter, less invasive, more personalized treatments.

Are you passionate about improving and expanding the possibilities of Orthopedics? Ready to join a team that's reimagining how we heal? Our Orthopedics teams help keep more than 6 million people moving each year while delivering State of the Art technology to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma and craniomaxillofacial; sports, extremities, and elective foot and ankle; spine; and robotics and digital surgery.

Your unique talents will help patients on their journey to wellness. Learn more at https://www.jnj.com/medtech

The Medical Director, Medical Affairs, Orthopedics role provides medical affairs support within an assigned platform / sub-platform (Sports / Joints) within the Orthopedics Business Unit of Johnson & Johnson MedTech. Leading with both outside-to-inside vision to assimilate opportunities of unmet patient and provider needs, and inside-to-outside vision to communicate the medical, surgical, and scientific content. This role provides medical input throughout product development , W orking 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, access, and adoption. A key activity is to support medical education to internal and external stakeholders, and commercialization activities.

Tasks / Duties / Responsibilities

INTERNAL PROCESS SUPPORT

• Work with cross-functional partners, including but not limited to R&D, Clinical Affairs, Regulatory Affairs, Health Economics & Market Access (HEMA) and Marketing to provide leadership with product development and commercial plans to support product launch, training content and delivery.
• Provide medical/surgical/scientific insights into design requirements, concept and prototype testing.
• Provide 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.
• Provide medical/surgical/scientific support for external regulatory inspections and audits, and internal audits.
• Provide expertise to support addressing complex medical information requests.
• Provide physician perspective, advice, guidance, and expertise as a medical expert for non-MD colleagues in medical affairs in matters requiring escalation or medical consultation.
• Provide expert medical/surgical/scientific support to Professional Education, Communications, Legal/HCC, HR Communications.
• Provide medical/surgical/scientific criteria in claims and collateral material review/approval.

LIFE CYCLE MANAGEMENT (LCM) SUPPORT

• Provide 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 Healthcare providers; review and approve medical content in Copy Approval process; and consults with Franchise Medical Director when needed.
• S/he will provide consultation in support of literature review, analysis and conclusions for Clinical Evaluation Reports (CER) and provide review of CERs and assists in preparation of periodic safety reports for assigned products.
• Assist in reviewing risk evaluation (PRE or PRA) documents.

INSIGHT MANAGEMENT AND BUSINESS DEVELOPMENT SUPPORT

• Engage with omni-channel external sources of information (key opinion leaders, medical societies, literature, social media, etc.) to capture, assess, and translate opportunities of unmet patient and provider needs and trends in the medical/healthcare ecosystems.
• Support business leaders by providing medical and scientific expertise and omni-channel insights to help shape optimal business development strategy and targets , including product launches, key scientific meetings, relationship management with leading research physicians, critical evaluation of current literature and competitive activity, and in other domains where medical and scientific expertise is required.
• Validate Target Product Profiles across the assigned innovation pipeline, including gathering and assimilating input from Medical Affairs leaders across key markets.
• Provide 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.

EVIDENCE GENERATION SUPPORT

• Assist medical evidence generation leaders to develop and execute global strategies for evidence generation 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 access, medical safety and post-marketing support.

Requirements

• 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 (beyond initial licensure) including clinical practice, dedicated research, or other related training/experience. Experience leading in medical affairs, clinical development, or related roles in research / medical device industry is preferred.
• Strong understanding of clinical trends and the related healthcare 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 all applicable standards / regulations requiring medical input, such as risk management, complaint management, reporting requirements, etc.
• Ability to be strong advocate for patient-centric decision making.
• Demonstrated ability to build successful relationships & develop partnerships with key business stakeholders & externally with regulators, investigators, etc.
• Strong business acumen
• US Board Certified Preferred
• 15% Travel Domestic and/ International

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson and Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, please email the Employee Health Support Center ( ra-employeehealthsup@its.jnj.com ) or contact AskGS to be directed to your accommodation resource.

The anticipated base pay range for this position is :
The anticipated base pay range for this position is 194000 to 334650

Additional Description for Pay Transparency:
The Company maintains highly competitive, performance-based compensation programs. Under current guidelines, this position is eligible for an annual performance bonus in accordance with the terms of the applicable plan. The annual performance bonus is a cash bonus intended to provide an incentive to achieve annual targeted results by rewarding for individual and the corporation's performance over a calendar/performance year. Bonuses are awarded at the Company's discretion on an individual basis. • Please use the following language: • Employees and/or eligible dependents may be eligible to participate in the following Company sponsored employee benefit programs: medical, dental, vision, life insurance, short- and long-term disability, business accident insurance, and group legal insurance. • Employees may be eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)). • This position is eligible to participate in the Company's long-term incentive program. • Employees are eligible for the following time off benefits: • Vacation - up to 120 hours per calendar year • Sick time - up to 40 hours per calendar year; for employees who reside in the State of Washington - up to 56 hours per calendar year • Holiday pay, including Floating Holidays - up to 13 days per calendar year of Work, Personal and Family Time - up to 40 hours per calendar year • Additional information can be found through the link below. https://www.careers.jnj.com/employee-benefits