Global Medical Affairs Leader, Pre-Approval Access

This job is with Johnson & Johnson, an inclusive employer and a member of myGwork – the largest global platform for the LGBTQ business community. Please do not contact the recruiter directly.

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 https://www.jnj.com

Job Function

Medical Affairs Group

Job Sub Function

Medical Affairs - MD

Job Category

People Leader

All Job Posting Locations:

Raritan, New Jersey, United States of America

Job Description

Job Description:

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow. Our Oncology team is focused on the elimination of cancer by discovering new pathways and modalities to finding treatments and cures. We lead where medicine is going and need innovators with an unwavering commitment to results. Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are seeking a highly skilled and dedicated physician to join our esteemed Global Medical Affairs team as a Global Medical Affairs Leader specializing in Pre-Approval Access (PAA) within the Oncology portfolio. This pivotal role entails a comprehensive review of patient cases to ascertain eligibility for access to innovative therapies under specific criteria, reflecting our commitment to patient care and regulatory compliance.

Key Responsibilities

• Conduct initial patient reviews as a Study Responsible Physician (SRP) to evaluate eligibility for innovative medicines within the pre-approval framework.
• Collaborate, when necessary, with treating physicians to gather detailed patient information and expertly assess individual cases against established clinical research protocols and treatment guidelines.
• Maintain robust working knowledge of clinical trial documentation, regulatory requirements, and operational procedures to ensure adherence to our pre-approval access policy.
• Engage proactively with Global Medical Affairs Leaders and Compound Development Team Leaders to integrate relevant data and insights for meticulous eligibility determinations.
• Foster strong partnerships with regional medical affairs teams and external stakeholders, including academic institutions and disease area experts, to enrich the review process and share perspectives on exceptional cases.
• Stay well-informed on our complete oncology portfolio to provide nuanced understanding and guidance during the patient review process.
  
  

Qualifications

• MD degree and significant oncology clinical experience are required.
• Demonstrated expertise in navigating multi-stakeholder environments with exemplary communication, planning, interpersonal, and problem-solving skills.
• Proven ability to prioritize, manage multiple projects, and collaborate effectively with diverse teams, including legal, regional medical affairs counterparts, delivery unit representatives, as well as other global medical affairs leaders and compound development team leaders.
• This position will either be based in Raritan, NJ or it will be remote based.
• This position may entail occasional travel for key meetings, approximately four times per year, underscoring the importance of in-person collaboration within this influential role.
• At Johnson & Johnson, we uphold the values of diversity and equal opportunity in our workforce. We encourage all qualified candidates to apply, recognizing the significance of varied perspectives in advancing healthcare solutions.
• If you are passionate about making impactful contributions to patient care through innovative medicine, we encourage you to consider this exceptional opportunity within our Global Medical Affairs team.
• The anticipated base pay range for this position is $160,000. to $276,000.
  
  

The anticipated base pay range for this position is $160,000 to $276,000

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.