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Medical Director, Gastroenterology Therapeutic Area - Medical Affairs
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Full-time
- Johnson and Johnson is recruiting for a Medical Director, Gastroenterology within our US Immunology Medical Affairs organization located in Horsham, PA.
- The Medical Director, Gastroenterology position will be responsible for leading the strategic development and execution of Medical Affairs sponsored and supported clinical programs (Phase IIIb/IV trials, any post-marketing requirements, investigator-initiated trials) for company products in the gastroenterology therapeutic area.
- Develop and execute (as Study Responsible Physician [SRP]) Medical Affairs sponsored clinical programs, including but not limited to Phase 3b/4 trials, registries, real-world evidence studies, investigator-initiated and/or collaborative studies in the Gastroenterology TA. Contribute/lead study design, protocol development, clinical study report and publication development.
- Contributes as a subject matter expert on previous and new data in support of US Immunology approved (or planned) GI drugs and indications, partnering particularly with respective marketing brand teams (as well as other commercial and IET partners, including RWVE, SCG, V&E Field and Med Info and other CAC partners).
- Actively partners with individuals in Gastroenterology TA and other groups inside and outside Medical Affairs (e.g. Biostats, GCO, Regulatory Affairs, QA and QC) to create Analysis Plans, safety data review for database locks and ensure compliance with study monitoring and other SOP/GCP requirements (and support audits, as needed).
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