Medical Director, Spine

At Johnson & Johnsonwe believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented treated and curedwhere treatments are smarter and less invasive andsolutions are 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 more at

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.

Job Function:

Medical Affairs Group

Job Sub Function:

Medical Affairs MD

Job Category:

Scientific/Technology

All Job Posting Locations:

Palm Beach Gardens Florida United States of America Raynham Massachusetts United States of America Warsaw Indiana United States of America West Chester Pennsylvania United States of America

Job Description:

DePuy Synthes part of the Johnson & Johnson Medical Devices Companies is recruiting for a Medical Director Orthopaedics Spine to be based in one of the following facility locations in Raynham MA West Chester PA Warsaw IN or Palm Beach Gardens FL. This is a part-time role anticipating a minimum of 3 days per week allowing 1-2 days per week of external clinical practice. The preferred arrangement is for this role is hybrid remote to be based at one of the locations listed above; however remote work with periodic travel to one of the locations may be considered on a case-by-case basis in certain circumstances for East Coast candidates.

About Orthopaedics

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

Are you passionate about improving and expanding the possibilities of Orthopaedics Our Orthopaedics teams help keep more than 6 million people moving each year while delivering clinical and economic value to surgeons and healthcare systems. Our teams build solutions for joint reconstruction; trauma; craniomaxillofacial; sports extremities and foot and ankle; spine; and robotics and digital surgery. Your unique talents will help patients on their journey to wellness. For more information visit .

This role provides medical affairs support within the spine platform. 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 this role provides strategic input to inform the innovative agenda within the Platform Portfolio. This role provides medical input throughout product development and life-cycle management including management of regulatory documents critical evaluation of clinical risk and input regarding potential patient safety issues. This role collaborates cross-functionally to support product development including evidence generation and dissemination to drive market registration access and adoption. This role supports medical education to internal and external stakeholders and commercialization activities to drive market adoption.

Tasks/Duties/Responsibilities

INSIGHT MANAGEMENT AND BUSINESS DEVELOPMENT SUPPORT (15%)

• 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.

INTERNAL PROCESS SUPPORT (50%)

• 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.

EVIDENCE GENERATION SUPPORT (15%)

• 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.

LIFE CYCLE MANAGEMENT (LCM) SUPPORT (15%)

• 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 of risk evaluation (PRE or PRA) documents.

Required education credentials and experience

Required Minimum Education is a MD or equivalent

• Completion of an accredited orthopedic surgery or neurological surgery residency and a minimum 1-year fellowship in spine surgery (or equivalent spine surgical training) is required.

• Candidate must have a minimum of 5 years relevant experience (beyond initial licensure) including clinical practice dedicated research or other related training/experience.

Qualifications continued:

• Previous experience leading in medical affairs clinical development or related roles in research / medical device industry is highly beneficial.

• Strong understanding of clinical trends and the related healthcare market environment with deep connections in the digital- med tech- ecosystem is required.

• 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. is required.

• Ability to be strong advocate for patient-centric decision making is essential.

• Demonstrated ability to build successful relationships & develop partnerships with key business stakeholders & externally with regulators investigators etc. is crucially important.

• Strong business acumen is essential

• The ability and willingness to travel approximately 15% Domestic and International. The travel estimate would be greater (30%) for talent who is not based at one of the previously mentioned locations.

The anticipated base pay range for this position is $204000 - $351900

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 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.

We will ensure that individuals with disabilities are provided reasonable accommodation to participate in the job application or interview process to perform essential job functions and to receive other benefits and privileges of employment. Please contact us to request accommodation.

Johnson & Johnson is an Affirmative Action and 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 or protected veteran status and will not be discriminated against based on disability.

For more information on how we support the whole health of our employees throughout their wellness career and life journey please visit

Required Skills:

Preferred Skills:

AI Judgement Integration Analytical Reasoning Clinical Research and Regulations Clinical Trials Operations Communication Consulting Design Mindset Healthcare Trends Industry Analysis Medical Affairs Medical Communications Medical Compliance Product Strategies Program Management Publications Management Scientific Research Strategic Thinking Team Management

The anticipated base pay range for this position is :

$204000.00 - $353050.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans employees are eligible to participate in the Companys consolidated retirement plan (pension) and savings plan (401(k)).

This position is eligible to participate in the Companys long-term incentive program.

Subject to the terms of their respective policies and date of hire employees are eligible for the following time off benefits:

Vacation 120 hours per calendar year

Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado 48 hours per calendar year; for employees who reside in the State of Washington 56 hours per calendar year

Holiday pay including Floating Holidays 13 days per calendar year

Work Personal and Family Time - up to 40 hours per calendar year

Parental Leave 480 hours within one year of the birth/adoption/foster care of a child

Bereavement Leave 240 hours for an immediate family member: 40 hours for an extended family member per calendar year

Caregiver Leave 80 hours in a 52-week rolling period10 days

Volunteer Leave 32 hours per calendar year

Military Spouse Time-Off 80 hours per calendar year

For additional general information on Company benefits please go to: Experience:

Director