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Global Medical Affairs Leader, Pre-Approval Access

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 degre...




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