- Sumitomo Pharma (Raleigh, NC)
- … Regulatory Affairs . The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/she will primarily function ... as the Regional Regulatory Leader (RRL) and/or Global ...Ideally with a minimum of 4 years focused in regulatory affairs The base salary range for… more
- Sumitomo Pharma (Raleigh, NC)
- …Regulatory Affairs (Oncology).** The Associate Director is part of the Global Regulatory Affairs (GRA) team based in the US. He/She will primarily ... function as a regional regulatory leader (RRL) and/or Global ...Ideally with a minimum of 4 years focused in regulatory affairs + Oncology product development experience… more
- Fujifilm (Research Triangle Park, NC)
- **Position Overview** The Director , Regulatory Affairs is a pivotal role providing regulatory expertise and leadership to the FUJIFILM Biotechnologies ... procedures, offering strategic direction throughout the organization. Additionally, the Director leads a team of regulatory specialists...+ Leads, mentors, and sets the objectives for the Regulatory Affairs team across the North Carolina… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- As a senior leader within Medical Affairs , the Executive Director will serve as a strategic thought partner and Chief of Staff to the Vice President of Medical ... capabilities aligned with Otsuka's vision, direction, and growth strategy. The Executive Director , Medical Affairs Strategy, Excellence & Operations will lead… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …Operations is a pivotal role within the Medical Excellence & Operations team within Global Medical Affairs . This role is responsible for overseeing 3 medical ... Include:** **Strategic Planning and Governance** + Lead the annual and multi-year Global and US Medical Affairs Strategic Planning process, overseeing the… more
- Chiesi (Cary, NC)
- …Purpose The primary responsibility of this role is to lead the PAH/PH-ILD US Medical Affairs team, ensuring alignment with Global Medical Affairs to execute ... the medical operating plan and Medical Affairs strategy for PAH/PH-ILD within the US, as part...of medicine development to all respiratory initiatives. Collaborating with global and local teams (Payer, Marketing, New Product Planning),… more
- Merck (Raleigh, NC)
- …workforce. **_Strategic Planning and Execution_** + In alignment with the Executive Director of US Medical Affairs , engages with cross-functional partners to ... **Job Description** **Role Summary** + The Regional Medical Scientific Senior Director Team Lead (RMSD TL) is a credentialed therapeutic and disease expert (MD, PhD,… more
- BD (Becton, Dickinson and Company) (Durham, NC)
- …**maker of possible** with us. **Position Summary** The Senior Manager of Regulatory Affairs reports directly to the Senior Director of Regulatory ... Pharmacy Automation products and associated Software and Accessories on a global basis from a Regulatory Affairs standpoint. Support will consist of new… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …business development programs. + Build professional network with key stakeholders outside of Global Regulatory Affairs to identify regulatory ... Description** + Oversee the capture, review, and dissemination of global regulatory news, public commenting opportunities, new...technical discipline preferred. + Minimum of 5 years of regulatory affairs experience. + Minimum 2-3 years'… more
- IQVIA (Durham, NC)
- …for the Data Management, Biostatistics, Programming, Medical Writing, Lifecycle Safety, and Regulatory Affairs functions - and will be responsible for achieving ... ** Director , Data Sciences, Safety and Regulatory ,...Management, Biostatistics, Statistical Programming, Medical Writing, Lifecycle Safety or Regulatory Affairs field is beneficial. IQVIA is… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …documents, including INDs, IBs, clinical study reports, and NDAs/BLAs. + Collaborate with regulatory affairs on interactions with global health authorities. ... on the large global clinical trials and regulatory filing activities. The Senior Director , GCD...trial implementation and management. + Complete understanding of the global regulatory requirements. + Working knowledge of… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …relevant company SOPs, GPP (Good Publication Practices), ICMJE guidelines, and global regulatory /legal requirements, establishing governance frameworks to ensure ... Collaborate with the CNS Medical BU Lead and cross-functional teams (eg, Global Integrated Evidence & Innovation, Clinical Development, Regulatory , Commercial)… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …congress activities + Collaborate with Medical Affairs , Clinical Development, Global Integrated Evidence & Innovation (GIE&I), Regulatory , and Commercial ... outcomes through deep scientific understanding and collaborative partnerships. The Associate Director partners closely with global and regional cross-functional… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …, Medical Communications Lead, CNS Lead, and cross-functional teams (eg, Global Integrated Evidence & Innovation, Clinical Development, Regulatory , Commercial). ... accurate, evidence-based, and compliant with internal policies and external regulatory requirements. + Collaborate cross-functionally with Medical Affairs ,… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …relevant company SOPs, GPP (Good Publication Practices), ICMJE guidelines, and global regulatory /legal requirements, establishing governance frameworks to ensure ... with the Nephrology & Immunology BU Lead and cross-functional teams (eg, Global Integrated Evidence & Innovation, Clinical Development, Regulatory , Commercial)… more
- Edwards Lifesciences (Raleigh, NC)
- …Contractors (MAC), Medicaid, Veteran Affairs (VA) and commercial payers. **The Director , Global Health Economics and Reimbursement will reside in either ... us and be part of our inspiring journey. The Director , Global Health Economics and Reimbursement is...collaborating cross-functionally with teams such as Sales, Marketing, Clinical, Regulatory , Legal, and Government Affairs to address… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …study report (FSR), including authoring statistical sections. + Discusses strategies with Global Clinical Development and Regulatory Affairs regarding study ... team and key stakeholders across different functional areas such as clinical, regulatory affairs , asset management, safety and clinical operation. + Familiar… more
- United Therapeutics (Research Triangle Park, NC)
- …procedures (SOPs). Will support strategic clinical product development as well as Global Medical Affairs . + Provide medical expertise, advice, and guidance ... which transplant is not currently an option. The Medical Director - Medical Monitoring will ensure individual subject safety...during studies as and when they are notified to Global Drug Safety to assist in identifying any emergent… more
- Otsuka America Pharmaceutical Inc. (Raleigh, NC)
- …internal Standard Operating Procedures (SOPs), Good Publication Practices (GPP), and global regulatory guidelines **Medical Information Content Generation** + ... product strategy and scientific messaging. + Collaborate cross-functionally with Medical Affairs , Regulatory , Legal, and Commercial teams to ensure consistency… more
- BD (Becton, Dickinson and Company) (Durham, NC)
- …PSO provide guidance to successfully deliver best-in-class secure products, consistent with global regulatory requirements over the lifecycle. This role works in ... makers of possible** BD is one of the largest global medical technology companies in the world. Advancing the...partnership with R&D, Enterprise Security, Quality, Regulatory Affairs , and leaders at corporate, regional,… more