- Takeda Pharmaceuticals (Lexington, MA)
- …investigational and/or registration strategies for assigned products as GRA CMC Product Lead and/or team lead. Assigned products include genetically modified cell ... essentials to address and overcome challenges that arise during development and commercialization . + Coaches and develops people and teams, recruits and rewards 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 ... commercial, and other functional areas to align regulatory strategy with overall product development and business objectives. + Provide expert guidance on regulatory… more
- Takeda Pharmaceuticals (Boston, MA)
- …as the Global Market Access Lead, GI/Rare._** _This position sits in The Global Product & Launch Strategy (GPLS) group is part of our Global Portfolio Division ... spanning over 70 countries. Our GPLS organization is responsible for our global product strategy organization focused on fueling the growth of Takeda through our… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …team members during development of promotional materials or other types of product communications to provide comprehensive regulatory compliance guidance. + Ensures ... product promotional materials are submitted to OPDP on Form...authorities. Otsuka America Pharmaceutical Inc., Otsuka Pharmaceutical Development & Commercialization , Inc., and Otsuka Precision Health, Inc. ("Otsuka") does… more
- Takeda Pharmaceuticals (Lexington, MA)
- …c) Reference Standard Management; d) GMP Quality Systems + Contribute to product development from Research to Commercialization by collaborating with multiple ... 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)
- …with the various groups and leadership involved in the development and commercialization of biomarkers, diagnostic tests and digital tools to ensure goals/objectives ... trends that impact both the regulatory and access environments to strengthen product development plan(s) and adopt regulatory strategies in a timely manner. +… more
- Bristol Myers Squibb (Cambridge, MA)
- …+ Will create a Clinical Development strategy to develop programs beyond commercialization and launch and into lifecycle management Leadership and Matrix Management ... through Regulatory + The candidate must be comfortable with cross-functional drug and product development teams and managing in a matrix environment + In addition,… more
- Takeda Pharmaceuticals (Boston, MA)
- …abreast emerging innovation in data products, advanced analytical technologies, product software/hardware platforms or digital health technologies. Takeda has ... + Strong understanding of DD&T innovations serving drug discovery, development commercialization process and functions + Deeply networked in the DD&T ecosystem… more
- ThermoFisher Scientific (Waltham, MA)
- …in the development of innovative Protein production products. Reporting to the Director , Product Management - Protein Production, the position is critical ... will you do?** + Lead & manage programs from concept to commercialization (full product lifecycle) + Responsible and accountable for life cycle management of … more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …that is excited to work in a high-priority role designed to support a new product launch in ADHD, the first for Otsuka in this therapeutic area. The Senior ... Product Manager, HCP Marketing ADHD will be responsible for...of marketing programs. This individual will report to the Director , HCP Marketing Lead. This position requires a highly… more