- CHRISTUS Health (Alexandria, LA)
- …programs as needed to comply with diverse healthcare laws or regulations Monitors regulatory compliance of all healthcare practices to ensure no violations ... Clinical Policies and Standards Monitors different types of clinical practice to ensure compliance with standards...different types of clinical practice to ensure compliance with standards Evaluates existing and evolving standards and… more
- Merck & Co. (Upper Gwynedd, PA)
- …in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; and Assist the Executive Director /AVP in ... medicines span all phases of clinical development (pre- clinical to post-licensure). The Senior Director will...of Action and Milestones (POA&M), Regulatory Affairs Compliance , Regulatory Compliance {+ 5… more
- Merck & Co. (North Wales, PA)
- …to ensure GRACS contractual obligations and commitments are met while maintaining regulatory compliance . - Work closely with the Corporate Business Development, ... Regulatory Affairs, Pharmacovigilance, Regulatory Affairs Compliance , Regulatory Affairs Management, Regulatory Compliance , Regulatory … more
- Merck & Co. (Boston, MA)
- …monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director May Be Responsible For: Evaluating pre- clinical and ... in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects; and assist the Executive Director and/or… more
- Merck & Co. (Rahway, NJ)
- …effective, innovative medicine.Summary, Focus and Purpose:The Cardiovascular and Respiratory Clinical Research Director -has primary responsibility for planning ... cardiovascular and respiratory medicines span all phases of clinical development (pre- clinical to post-licensure). The Director will manage the entire cycle… more
- Formation Bio (New York, NY)
- …new treatments to patients faster and more efficiently.About the PositionThe Senior Director , Regulatory Affairs lead is responsible for developing and directing ... progress because of the high cost and time of clinical trials. Recognizing that this development bottleneck may ultimately...the regional regulatory strategy, objectives, policies, and programs pertaining to developing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the programming standards and practices, SOPs, external/internal data standards, Good Clinical Practices (GCPs), applicable regulatory requirements, and other ... areas centered around rare diseases and immune disorders. Job Summary: The Director of Data Management (DM) Reporting provides leadership in Data Management… more
- Insmed Incorporated (San Diego, CA)
- …strategy, identifying risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the development of assigned programs in ... future of science, we're in. Are you?About the Role:The Director , Regulatory Affairs will serve as the...therapy or orphan (rare) diseasesPrior experience serving as the regulatory lead on cross functional teams (CMC, clinical… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …target product profile (TPP) development, due diligence projects, and clinical - regulatory compliance . ResponsibilitiesEssential Duties and Responsibilities ... and execute clinical trials for respiratory products, ensuring compliance with regulatory requirements.Collaborate with cross-functional teams to develop… more
- Eisai, Inc (Nutley, NJ)
- …15 or more years significant clinical pharmaceutical experience (ie, clinical development or operations, regulatory compliance ).Substantial experience in ... and oversight of the Quality management system. This role is responsible for Good Clinical Practice (GCP) and for assuring the compliance of projects, products… more
- Merck & Co. (Rahway, NJ)
- …applicable laboratory testing regulations.Experience ensuring compliance of a clinical laboratory with regulatory standards.Experience with the development ... clinical implementation and advancing digital pathology within our company's clinical therapeutic pipeline.The Principal Scientist ( Director ) will have the… more
- Insmed Incorporated (NJ)
- … regulatory submissions for compounds in various phases of clinical development, marketing applications, and post-approval lifecycle activities by working with ... meetings.Provide interpretation of applicable FDA/EMA/ICH/WHO global regulations to ensure CMC compliance within regulatory filings. Keep abreast of all… more
- Eisai, Inc (Baltimore, MD)
- …and make a difference. If this is your profile, we want to hear from you. Director , Clinical Quality Assurance The Director , Clinical Quality Assurance ... for Good Clinical Practice (GCP) oversight, and for assuring the compliance of projects, products and programs with Eisai's Standard Operating Procedures (SOPs),… more
- Legend Biotech USA, Inc. (Philadelphia, PA)
- …guiding toxicology strategy from early research through IND-enabling studies and into clinical development, ensuring regulatory compliance and scientific ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Sr. Director of Toxicology as part of the Clinical Development team based in… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and establishes the oversight model for timely and quality delivery and regulatory compliance of outsourced activities.- Ensures inspection readiness of all ... data review and cleaning, database lock), to ensure data quality/integrity and regulatory compliance - Ensures that Data Management Plans are consistent and… more
- Merck & Co. (Rahway, NJ)
- …across the entirety of our non-sterile and sterile clinical portfolio. The Director is responsible for ensuring cGMP compliance and operational excellence in ... Recruitment, Process Analytical Technology (PAT), Professional Networking, Raw Materials, Regulatory Compliance , Regulatory Submissions, Release Testing,… more
- Merck & Co. (North Wales, PA)
- …responsible for the formulation and execution of automation strategy in Global Clinical Trial Operations and all the support activities within their functional area. ... This includes working with stakeholders across Global Clinical Trial Operations (GCTO)and other relevant teams, driving the strategy from ideation to value… more
- Novo Nordisk Inc. (Boulder, CO)
- …of technical teams required Experience working to standards required for regulatory compliance of Aseptic Processing facilities required Understanding of ... such as Quality Assurance/ Control, Chemical Development, Program Management, Regulatory , Analytical Development, Materials Management, and Clinical Supply… more
- Genmab (NJ)
- …for the US HEOL Team to ensure adequate and appropriate communication of Genmab's clinical and economic value messages. The Director , HEOL Team Lead will work ... and adherence to corporate complianceCurrent working knowledge of US-specific legal, regulatory , and compliance regulations and guidelines relevant to industry… more
- Merck & Co. (North Wales, PA)
- …Research, Pain Management, Pharmaceutical Development, Regulatory Affairs Compliance , Regulatory Compliance , Scientific Leadership, Scientific ... clinical to post-licensure). With a focus on late-stage development, the Senior Director will manage the entire cycle of clinical development, including study… more
