in support of clinical regulatory requirements. Ongoing Standards Compliance Stays current with all evolving regulatory... among direct reports. Collaborate with the Senior Director, Quality Assurance and Regulatory Compliance, and other members of the...
effective collaboration on labeling strategies. Regulatory Compliance & Precedent Analysis. Conduct precedent searches... with Global Regulatory Leads and escalate issues when necessary, proposing risk mitigation strategies. Requirements: 10...
Senior Director Clinical Pharmacology Lead The Clinical Pharmacology Lead (CPL) Oncology will bring an extensive... with Pharmacokinetics specialists, Translational Sciences, Pharmacometrics, Research, Clinical Development, Regulatory, Medical Affairs...
. Job Description Associate Director, Quality provides Quality oversight for Bicycle’s development programs, ensuring compliance with applicable... of Development Quality. Collaborate with global program teams to ensure protocol, procedural, GCP / regulatory compliance...
Job Title: Associate Director, Clinical Operations, Immunoassay Job Location: United States Job Location... The Associate Director, Clinical Operations Lead for Immunoassay (IA), Clinical Operations is responsible for the planning...
of complex business models. Ensure comprehensive clinical, financial, legal/regulatory, operational and other risk-related... in optimizing clinical operations and improving patient care outcomes, with knowledge of regulatory requirements and quality...
Clinical Research Director (CRD), Immunology & Inflammation (I&I) Therapeutic Area is responsible for the creation of the... global project team and internal partners such as clinical operations, translational medicine, regulatory affairs...
Job Title: Director, Clinical Pharmacology & Pharmacometrics Job Location: United States Job Location Type: Remote.... General Description The Director, Clinical Pharmacology & Pharmacometrics will be responsible for developing and executing...
, Investigator Brochures, Clinical Study Reports, regulatory submissions, and study-related documents. Advanced leadership skills... scientific, technical and clinical expertise in respiratory/immunology field Has a demonstrated track record in clinical...
program, promotes operational and compliance excellence, and for ensuring PV activities follow regulatory requirements...Reporting to the Senior Director of Drug Safety and Pharmacovigilance Operations, the Senior Manager, Contractor...
management of the vendors who help make our trials successful. This role will report to the Associate Director, Clinical... outsourcing and other Clinical Operations process improvement projects Collaborate with QA and compliance to ensure quality...
Senior Clinical Research Director (Sr CRD) is noted as the primary clinical lead for programs. The role requires a well... in compliance with Good Clinical Practice (GCP), applicable laws and regulations as well as applicable standard operating procedures...
of high-quality clinical and regulatory documents, from planning and coordination to the final draft. The individual... and objectives for the CTTD team that align with the company's overall strategy. Ensure compliance with regulatory guidelines: The...
ensuring compliance with GVP regulations. Partner and support EAs in ensuring conduct of non-interventional, observational..., and post-marketing surveillance (PMS) meet regulatory requirements and expectations considering Good Pharmacoepidemiology...
Director for its Portfolio Leadership Group. The primary function of this role will be to serve as a nonclinical safety... representative for assigned molecules across AbbVie’s diverse portfolio. As a safety representative, the Scientific Director...
teams, to ensure strategic alignment and executional excellence Ensure compliance with regulatory, legal, and corporate... and within budget Clear communication skills, both verbal and written Thorough understanding of regulatory, legal and compliance...
Job Title: Director, US Neurology - Consumer Marketing Location: Cambridge, MA About the Job The Director..., legal, regulatory, advocacy and other functions to ensure aligned objectives, understanding and implementation of the brand...
with significant experience within related functions (e.g. Clinical Science, Clinical Operations, Research, Regulatory, CMC, Marketing.... Job Description Are you looking for a patient-focused, innovation-driven company that will inspire you and empower you to shine? Join us as an Associate Director...
of goals and an eye towards innovation. Ensure compliance with regulatory, legal, and corporate requirements... understanding of regulatory, legal and compliance requirements. Experience navigating medical, legal, regulatory process...
as well as regulatory teams to develop and plan clinical validation and registration plans for diagnostic products. Lead...Job Title: Lead, Sr. Director - In-Vitro Diagnostics Development Location: Cambridge, MA - Bridgewater, NJ...
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