-disciplinary stakeholders (e.g. biostatistics, clinical development and regulatory affairs) to drive the generation of actionable...Company Overview Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives...
-disciplinary stakeholders (e.g. biostatistics, clinical development and regulatory affairs) to drive the generation of actionable...Company Overview Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives...
Learning and Capabilities is responsible for developing and implementing the Medical Affairs training strategy, including... allocation for the Medical Affairs organization, working with the Senior Director of Medical Operations and peers to establish...
colleagues (including Global Portfolio Marketing, Market-Engagement Services, Sales & Commercial Delivery, Regulatory, Medical... Affairs) and will work collaboratively to define and implement a marketing strategy to ensure commercial success. Roles...
We are seeking an experienced Associate Director, Scientific Communications as part of the North America Medical Affairs team to lead...Company Overview Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives...
-approval and post-approval, as needed. Collaborates with NDA teams assessment, strategy and execution of key Regulatory..., CCDS, USPI, SmPC and other local labels, as applicable. Collaborates with Regulatory Affairs to develop responses...
We are seeking an experienced Associate Director, Scientific Communications as part of the North America Medical Affairs team to lead...Company Overview Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives...
and planning bet medical functions (Global Medical Affairs, Safety, Clinical Operations, Biostatistics, Epidemiology and Medical..... This role is usually assigned to 2 or more programs, , serving on strategic teams (e.g., disease strategy team) and providing...
and planning bet medical functions (Global Medical Affairs, Safety, Clinical Operations, Biostatistics, Epidemiology and Medical..... This role is usually assigned to 2 or more programs, , serving on strategic teams (e.g., disease strategy team) and providing...
-functional collaboration in Biostatistics, Clinical Development, Data Management, and Regulatory Affairs. Demonstrated... and platform levels. Lead programming support for global submission (NDA, BLA, MAA, PMDA), including integrated datasets, TLFs...
to global regulatory submissions (NDA, BLA, MAA), including submission ready datasets, TLFs, define.xml, and reviews' guide... of Statistical Programming to define and execute a comprehensive programming strategy, including vendor oversight, process automation...
, and delivery of technology solutions that enable global R&D, Regulatory, or Global Development functions. This role owns... ability to make tough talent decisions. Deep expertise in Regulatory Affairs, Clinical Development, and R&D technology...
, biostatistics, regulatory affairs, and medical affairs, to ensure the successful execution of clinical development programs. Build... in accordance with the protocol, regulatory requirements, and ethical standards. This includes monitoring study progress, reviewing...
and regulatory filings; Author and/or provide senior review of clinical protocols, medical affairs and regulatory documents/filings... development programs. Provide guidance and direction to fluid members of the group focused on biomarker strategy development...
Development, Regulatory Affairs and Patient Safety. You will be responsible for: Key Areas of Responsibility will include..., Regulatory Affairs and Patient Safety Create a business partnership and ensure close cooperation between all functions and IT...
Director, and Medical Science Liaisons (MSLs), while collaborating closely with Global Medical teams, Regulatory, US Commercial... indications. Serve as the primary medical point of contact for Nephrology across US Commercial, Global Medical, and Regulatory...
-functional teams, including commercial, regulatory, legal, R&D and medical affairs, to ensure cohesive communication strategies... that all information I submit in my employment application is true to the best of my knowledge. Job Description Takeda is a global...
, reporting to the Senior Director of Government Pricing within the US Market Access department. This rapidly expanding function... reporting, G2N forecasting, contracting strategy, and compliance. The ideal candidate is passionate about patient access...