- Direct Counsel (Washington, DC)
- …York, or Chicago (hybrid work schedule available) Direct Counsel is seeking a Junior Healthcare Regulatory Associate to join a nationally recognized Am Law 100 ... Qualifications: JD from an accredited law school 2-3 years of relevant healthcare regulatory experience, ideally from an Am Law 100 firm Licensed to practice… more
- Merck & Co. (Rahway, NJ)
- …experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement experience ... System Associate for the Labeling Operations area within the GRACS Regulatory Innovation & Information Management organization.Primary area of responsibilities will… more
- Merck & Co. (Upper Gwynedd, PA)
- …Pharmaceutical CMC is responsible for developing and implementing CMC regulatory strategies for our company's pharmaceutical pipeline products in accordance ... assigned development products. -Primary responsibilities include, but are not limited to: Regulatory Responsibilities: Serve as a CMC Product Lead for assigned… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description:The Vice President, Regulatory Affairs, General Medicine, will contribute to the mission and vision of the Global Regulatory ... strategy with US FDA and global health authorities to advocate advanced regulatory strategies for novel medicines.Contributing to the continuous improvement of the… more
- Eisai, Inc (Nutley, NJ)
- At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care ... to hear from you. Job Summary The Executive Director, Regulatory Affairs will provide leadership and direction for the...Affairs will provide leadership and direction for the global regulatory aspects of Eisai's products under development and post… more
- Prime Healthcare Management Inc (Ontario, CA)
- …implementing AI/ML solutions for healthcare data analysis Knowledge of healthcare regulatory requirements (HIPAA, CMS regulations) Experience with SQL, NoSQL ... Overview Prime Healthcare is an award-winning health system headquartered in...an award-winning health system headquartered in Ontario, California. Prime Healthcare operates 51 hospitals and has more than 360… more
- Randstad (Worcester, MA)
- …for interpersonal communication and automated devices Skills Entering Data Data Entry Healthcare Regulatory Compliance - Other Problem Solving Time Management ... This position is essential to compliance with regulatory requirements and individual expectations. This role serves...equivalent, or two years college education (or knowledge of healthcare field equal to 2 years college preparation). Reliable… more
- Merck & Co. (Rahway, NJ)
- …momentum, and an inspiring mission to achieve new milestones in global healthcare . The Biologics and Biopharmaceutics team is responsible for the research and ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Merck & Co. (North Wales, PA)
- …design, computing software and data management; a general understanding of worldwide regulatory requirements; and with good clinical trial experience in Phase II/ ... designing and analyzing clinical trials in support of worldwide regulatory submissions.This position involves interaction with Medical, Data Coordination,… more
- Hartford HealthCare at Home (Bridgeport, CT)
- …Health Services which promote the health and safety of all Hartford HealthCare colleagues. Ensuring regulatory compliance with OSHA Standards, CDC Guidelines, ... every moment matters. Every day, more than 40,000 Hartford HealthCare colleagues come to work with one thing in...invite you to become part of Connecticut's most comprehensive healthcare network. The story of Hartford HealthCare … more
- Merck & Co. (Rahway, NJ)
- …with the company's business goals, and quality and regulatory compliance.-Essential Duties and Responsibilities:Strategic Leadership and Project Management:Provide ... with receiving sites, drug product partners, and Technical Product Leaders, regulatory and quality.Provide Voice of Manufacturing input to early development teams… more
- Merck & Co. (Rahway, NJ)
- …of clinical development, including study design, placement, monitoring, analysis, regulatory reporting, and publication.Specifically, the Director may be responsible ... closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development projects;… more
- Merck & Co. (Durham, NC)
- …The Durham EHS Lead influences site leadership ensuring compliance with regulatory requirements, corporate standards, policies, and procedures related to EHS as ... of required reports to site, divisional and/or corporate management and regulatory agencies.Manage budgetary & capital needs to support EHS initiatives, projects… more
- Merck & Co. (Rahway, NJ)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... under supervision in Late Development Statistics. --Interacts with Clinical, Regulatory , Statistical Programming, Data Management and other company Research… more
- Merck & Co. (Durham, NC)
- …process understanding Author, review, and/or edit technical documents to support regulatory filings including technical reports and risk assessments Author or ... to meet project, production and supply timelines. Lead aspects of regulatory inspections by presenting and defending technical documentation, investigations, and… more
- Merck & Co. (South San Francisco, CA)
- …enhance document authoring processes, thereby improving efficiency and compliance in regulatory submissions.The candidate will play a key role in developing, ... GenAI approaches to streamline the creation and quality control (QC) of regulatory submission documents. The candidate will be part of an interdisciplinary team… more
- Merck & Co. (San Francisco, CA)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... analyses- Developing and maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics, authoring regulatory… more
- Merck & Co. (Rahway, NJ)
- …external vendors and partners, creating an aligned, quantitative and model-informed regulatory framework to impact strategies and decisions of drug discovery and ... reporting and interpretation of data. Maintain a comprehensive understanding of global regulatory expectations and shape, present and defend regulatory documents… more
- Merck & Co. (Rahway, NJ)
- …process validation, second generation process development and authoring of regulatory submissions.-Under the general scientific and administrative direction of the ... next generation process development and characterization, process validation, and regulatory submission authoringIn this role, the successful candidate will be… more
- Merck & Co. (Rahway, NJ)
- …cross-functional teams to foster collaboration and innovation.Document Excellence: Author regulatory and technical documentation, ensuring all processes align with ... molecules.Familiarity with late-stage process development, process characterization, process validation regulatory submissions, and working with external contract organizations.Proficiency in… more
