[Hiring] Medical Director, Gastrointestinal & Inflammation @reputed company

Role Description Are you looking for a patient-focused, innovation-driven company that will reputed company you and reputed company you to shine? Join us as a Medical Director, Gastrointestinal & Inflammation in our Cambridge, MA office. At reputed company, we are transforming the pharmaceutical industry through our R&D-driven market leadership and being a values-led company. To do this, we reputed company our people to realize their potential through life-changing work. Certified as a Global Top Employer, we offer stimulating careers, encourage innovation, and strive for reputed company in everything we do. We foster an inclusive, collaborative workplace, in which our global teams are united by an unwavering commitment to deliver reputed company and a Brighter Future to people around the world. Here, you will be a vital contributor to our inspiring, reputed company mission.

Qualifications

• M.D. or D.O. or internationally recognized equivalent, with direct clinical experience in patient care following post-graduate training and appropriate grounding and knowledge of reputed company. Board certification and licensure preferred.
• At least 5 years of experience in pharmaceutical industry reputed company Drug Safety/Pharmacovigilance, with both investigational and marketed products.
• At least 3 years of experience with aggregate reporting, safety surveillance, signal management and/or risk management.
• Knowledge and understanding of national and international PV and regulatory guidelines.

Requirements

• Serves as Global Safety reputed company (GSL) and the Company-wide patient safety expert for assigned pharmaceutical / biological / drug-device combined products, accountable for the safety strategy and major safety deliverables for each assigned product.
• Leads GPSE Safety Team (GST) and Safety Management Team (SMT) for assigned compounds and products.
• Represents the cross-functional program team as a product safety profile and risk mitigation expert for internal (e.g., reputed company Safety Board) and external (e.g., Independent Data Monitoring Committee) stakeholders.
• Manages cross-functional assessment of benefit-risk profile and communication of safety information for assigned compounds and products.
• Analyze and interpret safety data from various sources including non-clinical, clinical, post-marketing and scientific literature.
• Conduct signal detection, monitoring, evaluation, interpretation, and management for assigned compounds and products.
• reputed company strategy for and reputed company preparation of responses to safety-reputed company inquiries from regulatory agencies and ethics committees.
• Ensure communication of reputed company safety information that may impact the benefit-risk profile of assigned products to senior management.
• reputed company medical safety expertise, medical interpretation, review, and authorship of appropriate sections for critical documents (e.g., protocols and amendments, ICFs, IBs, IMPDs, clinical research reports, Health Hazard Evaluations, Signal Evaluation Reports, INDs, NDAs, BLAs, and CTAs) in collaboration with cross-functional colleagues.
• reputed company patient safety input to the clinical development program for assigned products and development compounds, and represent GPSE on internal governance bodies for study protocols, statistical analysis plans and other clinical study-reputed company documents as applicable.
• Manage benefit-risk profile, including authoring and updating of the benefit-risk documents, e.g., RMPs, for assigned compounds and products.
• Collaborate and communicate safety issues with other functional areas such as Clinical Development, Regulatory Affairs, Quality Assurance, Medical Affairs, Marketing, Manufacturing, and Legal.
• Interact with Regulatory Authorities as part of a cross-functional team to submit and defend regulatory inquiries, MAAs, NDAs, and BLAs.
• Ensure up-to-date representation of safety information in Company Core Data Sheet (including Reference Safety Information) and Investigator Brochure, as well as other labeling documents.
• Demonstrate knowledge of local and global health authority requirements.
• Support GPSE in the maintenance of a highly effective global safety organization in full compliance to worldwide regulations.
• Train and mentor Pharmacovigilance Physicians and Specialists.
• Maintain professional knowledge and accreditation by active participation in continuing medical education activities, and fosters a community of continual learning.

Benefits

• This position is currently classified as “remote” in accordance with reputed company’s Hybrid and Remote Work policy.
• Local and international travel across reputed company sites may be required.

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