- Rhythm Pharmaceuticals (Boston, MA)
- …quarterly business reviews of programs + Ensure all speaker programs adhere to regulatory guidelines (eg, FDA , PhRMA, Sunshine Act) + Manage documentation, ... expense tracking, and reporting for transparency and audit readiness + Collaborate with Legal and Compliance teams to update policies and procedures + Create marketing materials for the field teams/HQ to promote the programs + Supervise and handle financial… more
- Danaher Corporation (Boston, MA)
- …if you also possess previous experience in: + Drug Development sales cycle and regulatory approval framework ( FDA ) + cGMP manufacturing + Sales Coaching and ... Value Selling experience Aldevron, a Danaher operating company, offers a broad array of comprehensive, competitive benefit programs that add value to our lives. Whether it's a health care program or paid time off, our programs contribute to life beyond the… more
- Hologic (Boston, MA)
- …+ Familiarity with radiology clinic IT environments, medical imaging workflows, and regulatory requirements (eg, FDA , HIPAA) + Strong grasp of cloud-based ... technologies, SaaS models, and integration with healthcare information systems (PACS, RIS, EMR) + Proficiency in market analysis, competitive intelligence, and user research to inform product strategy and roadmap + Knowledge of data privacy, cybersecurity, and… more
- Wolters Kluwer (Waltham, MA)
- …engineering teams to operate at high velocity while ensuring strict compliance with global regulatory standards such as FDA , EU MDR, ISO 13485, and IEC 62304. ... managing the software development plan and partnering with engineering, quality, and regulatory team members to aligning the process with agile and lean engineering… more
- Editas Medicine (Cambridge, MA)
- …through nonclinical development including managing GLP and non-GLP studies, and regulatory submissions + Familiarity with FDA /EMA/ICH guidelines and proven ... and oversee execution of GLP and non-GLP toxicology studies to support regulatory submissions and interactions with health authorities, including the authoring of… more
- Medtronic (Newton, MA)
- …quality and reliability efforts for Cardiac Ablation Solutions products, ensuring compliance with regulatory standards such as FDA CFR, MDR, IEC 62304, and ISO ... develop reliability engineering program strategies to achieve Medtronic, customer, and regulatory reliability objectives for assigned programs. + Review and support… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …systems and leading cross-functional teams. + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Expertise in LMS ... end-to-end management of global training operations, ensuring compliance with regulatory requirements, operational efficiency, and alignment with corporate quality… more
- Bristol Myers Squibb (Devens, MA)
- …gained through direct support of commercial manufacturing. + Extensive knowledge of FDA /EMEA cGMPs and other global regulatory compliance guidelines (eg, ICH) ... development plans and assist in the creation of strategic objectives for regulatory filings. + Provides leadership and statistical SME support for complex data… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …planning of regulatory interactions and Provides tables and listings for FDA meeting briefing packages. + Support statistical needs for market access and ... statistical expertise/input in the drug development including clinical development plan and regulatory submission strategy. This is a strategic and critical role in… more
- Otsuka America Pharmaceutical Inc. (Boston, MA)
- …and managing cross-functional teams. + Strong understanding of R&D functions and the regulatory landscape (GxP, ICH, FDA , EMA, etc.). + Proven ability to ... design and deliver impactful learning programs using adult learning principles. + Experience with learning technologies (eg, LMS, virtual learning platforms) and data-driven training strategies. + Excellent communication, collaboration, and stakeholder… more