- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Position Summary** The Director , Early Commercial Planning is responsible for supporting early-stage commercialization efforts, ensuring that Otsuka's pipeline ... commercialization. + **Portfolio Planning Support:** Assist in evaluating new product planning, pipeline prioritization, and business development opportunities to… more
- Fresenius Medical Center (Waltham, MA)
- …influencing regulatory decisions, managing complex global submissions, and ensuring successful product development, approval, and market access for FME's product ... NDSs, MAAs, etc..and other key regulatory submissions. + Collaborate with senior leadership in medical/clinical development, commercial, and other functional areas… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- **Job Summary** We are seeking an experienced and dynamic Executive Director of R&D Global Quality to join our team. This pivotal role will be responsible for ... mitigation of Quality risks from development through commercial registration and product distribution. **Job Description** + This critical leader will inspire and… more
- Takeda Pharmaceuticals (Boston, MA)
- …we do begins with our commitment to putting patients first. As a Director , Technology Business Partner for Global Development Operations, you will play a key ... solutions that support clinical trial operations, enhance data quality, and accelerate drug development - all while upholding Takeda's core values: Patient, Trust,… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …: Reporting to the Vice President, Global Medical Affairs, the Executive Director , CNS Strategy, Global Medical Affairs is a leadership position responsible for ... Otsuka prominence in CNS space + Provides input into regulatory documents, including product labeling + Accountable for resourcing of personnel and budget for Global… more
- Pfizer (Cambridge, MA)
- …clinical development, and related disciplines such as clinical pharmacology, biology, formulation, and drug product . + Experience in small molecule drug ... review the work of other colleagues. + Be at the forefront of model-based drug development (MBDD), evaluating risks and facilitating drug development in close… more
- Takeda Pharmaceuticals (Lexington, MA)
- …Reference Standard Management; d) GMP Quality Systems + Contribute to product development from Research to Commercialization by collaborating with multiple functions ... within the Pharmaceutical Science organization to improve analytical, process and product knowledge. Including the support of transfer of development assets from… more
- Takeda Pharmaceuticals (Boston, MA)
- …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...may impact the benefit-risk profile of assigned products to senior management. + Provide medical safety expertise, medical interpretation,… more
- Danaher Corporation (Boston, MA)
- …m (https://www.danaher.com/how-we-work/danaher-business-system) which makes everything possible. The Senior Principal, Regulatory Affairs is responsible for ... Diagnostics and digital pathology in the clinical oncology environment. The Senior Principal, Regulatory Affairs will provide oversight and lead global submission… more
- AbbVie (Cambridge, MA)
- …phases. Key Responsibilities: + The candidate will lead analytical teams associated with drug substance and drug product development and characterization of ... + Leverage prior experience leading analytical efforts focused on phase appropriate peptide drug substance and drug product development. + Experience… more