- United Therapeutics (Boston, MA)
- …are as follows:** **Who we are** We are the first publicly-traded biotech or pharmaceutical company to take the form of a public benefit corporation. Our public ... a brighter future for patients through the development of novel pharmaceutical therapies; and technologies that expand the availability of transplantable organs.… more
- Sanofi Group (Cambridge, MA)
- …digital technology, and develop customer support solutions. + Interface with medical, regulatory , and legal teams to create marketing materials. + Manage advertising ... forms of legal and statutory regulation within domain of responsibility, including compliance with applicable SOPs, industry codes of practice and best practices and… more
- GE HealthCare (MA)
- …and responding appropriately. . Ability to achieve objectives while operating in compliance with regulatory guidelines. About Us With 4000+ employees serving ... defining and executing a coherent go-to-market sales strategy. **Job Description** Our Pharmaceutical Diagnostics (PDx) business is the number one global supplier of… more
- Actalent (North Billerica, MA)
- …of investigations and deviations in accordance with internal procedures and regulatory expectations. + Facilitate and lead cross-functional team meetings focused on ... reports, CAPAs, and trend analyses to ensure clarity, scientific soundness, and regulatory readiness. + Monitor and track investigation metrics to identify systemic… more
- Sanofi Group (Cambridge, MA)
- …team and internal partners such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing + Advance ... full clinical study protocol + Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations + Review… more
- Sanofi Group (Cambridge, MA)
- …team and internal partners such as clinical operations, translational medicine, regulatory affairs, biostatistics, drug discovery, drug safety, marketing. + Advance ... full clinical study protocol. + Oversee the execution of clinical studies in compliance with internal SOPs, GCP, ICH guidelines and other regulations. + Review… more
- Takeda Pharmaceuticals (Boston, MA)
- …(SDTM and ADaM), medical terminology, clinical trial methodologies to ensure the compliance with regulatory agencies and data reporting standards; create and ... submission packages (Define.xml for CDISC standards, cSDRG and ADRG) for regulatory authorities; support post submission activities; build general and project level… more
- Adecco US, Inc. (Waltham, MA)
- …business objectives, quality initiatives and management, process improvement, compliance , and innovation. Applies therapeutic area expertise and indication-specific ... monitor and/or safety physician activities and supporting services across the pharmaceutical product life cycle. Encourages a culture of accountability and… more
- Regeneron Pharmaceuticals (Cambridge, MA)
- …seeking a highly skilled, self-motivated **Senior Validation Specialist- CSV** to ensure compliance of computerized systems with regulatory requirements in the ... validation activities to meet FDA and potentially other global regulatory standards such as 21 CFR Part 11, GAMP...and driving all CSV activities required to maintain quality compliance as per existing Policies and Procedures for RCM.… more
- Takeda Pharmaceuticals (Lexington, MA)
- …knowledge and optimize project planning + Coordinate and execute all legal/ regulatory /medical/ compliance reviews. Work with agencies to develop submissions, ... program and/or project management experience + 3+ years' experience in pharmaceutical -industry-focused marketing + Deep knowledge of digital analytics and social… more
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