collaborations with key internal and external partners, such as project leaders, research units, biostatistics, regulatory affairs... in Oncology. You will work in close collaboration with the Global Development Lead (GDL)and members of the development team...
collaborations with key internal and external partners, such as project leaders, research units, biostatistics, regulatory affairs... in Oncology. You will work in close collaboration with the Global Development Lead (GDL)and members of the development team...
-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...
, and Regulatory Affairs to ensure alignment and knowledge transfer. Review and approve technical protocols, development reports..., clone screening, characterization and cell line stability studies. Ensure regulatory-compliant cell line development...
teams, collaborating with Biostatistics, Clinicals, and Regulatory Affairs to ensure delivery of submission-ready outputs... a plus. Strong knowledge of regulatory requirements (FDA, EMA, ICH, and other global guidelines). Hands-on experience with industry data...
to global regulatory submissions (NDA, BLA, MAA), including submission ready datasets, TLFs, define.xml, and reviews' guide... with SOPs and regulatory standards. Collaborate with Biostatistics, Clinical Development, Data Management, and Regulatory...
, 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 requirements, client's customers, markets, business operations, and emerging issues. Oversees project-related... of scientific content of protocols, Investigator Brochures, Clinical Study Reports, regulatory submissions and responses...
and regulatory filings; Author and/or provide senior review of clinical protocols, medical affairs and regulatory documents/filings... and implementation. Liaise with relevant stakeholders in clinical, regulatory, and commercial to coordinate and align biomarker...
collaborations with key internal and external partners, such as project leaders, research units, biostatistics, regulatory affairs... in Oncology. You will work in close collaboration with the Global Development Lead (GDL)and members of the development team...
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...
Company Overview Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives.... This role will report into the Associate Director, Field & Marketing Operations. Responsibilities and Duties Speaker...
Company Overview Rhythm is a global, commercial-stage biopharmaceutical company committed to transforming the lives.... This role will report into the Associate Director, Field & Marketing Operations. Responsibilities and Duties Speaker...
: As Counsel, Market Access, at the director level, you will be responsible for providing day-to-day legal support to the Patient... for inline and launch products within the US Market. You will report to the Head Counsel, Takeda Global Oncology...
with Clinical Operations, CMC, Quality, and Regulatory Affairs to align on assumptions, ensuring robust supply availability... of any temperature excursions in compliance with quality and regulatory standards. Coordinate all global distribution activities...
, reporting to the Senior Director of Government Pricing within the US Market Access department. This rapidly expanding function... proposals, solve for “what if” type questions from stakeholders, and determining any impact of regulatory changes. This position...
– US Market Access fellowship, based in Boston, MA. About Vertex Vertex is a global biotechnology company that invests... polycystic kidney disease, type 1 diabetes, and myotonic dystrophy type 1. Vertex was founded in 1989 and has its global...
partners, including Medical Affairs, Legal, Regulatory, Patient Services, Market Access, Data & Analytics, Market Insights..., Competitive Intelligence, Global Marketing, and US Commercial Field teams to support promotional activities Qualifications...