- Merck & Co. (San Diego, CA)
- …biological sciences, chemistry, or related discipline with 10+ years of relevant drug development, clinical, or regulatory experience.M.D. or Ph.D./Pharm D with ... Job DescriptionThe Global Regulatory Liaison is responsible for developing and implementing... Liaison is responsible for developing and implementing worldwide regulatory strategies for assigned projects within the Immunology therapeutic… more
- Merck & Co. (North Wales, PA)
- …reporting processes (SOPs) and software development life-cycle (SDLC)US and/or worldwide drug or vaccine regulatory application submission experience including ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (North Wales, PA)
- …procedures, SAS/MACRO, SAS/GRAPH and systems and database expertise;US and/or worldwide drug or vaccine regulatory application submission experience at the ... the statistical programming activities for multiple and/or large/complex late-stage drug /vaccine clinical development projects.Develop and execute statistical analysis and… more
- Merck & Co. (Rahway, NJ)
- … drug discovery and development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within ... methods) with ability to understand how MIDD can drive portfolio and regulatory decisionsDeep knowledge of drug development, pharmacokinetics and pharmacology… more
- Merck & Co. (North Wales, PA)
- …that include coordinating the activities of a programming team.US and/or worldwide drug or vaccine regulatory application submission experience at the leadership ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Merck & Co. (Rahway, NJ)
- …with internal and external stakeholders such as drug substance, drug product, device, analytical, regulatory , project leaders, manufacturing sites, and ... who are responsible for delivering robust packaging systems for cell banks, drug substance, drug product, and finished goods.- Development activities include… more
- Insmed Incorporated (San Diego, CA)
- …Women™, Best Workplaces for Millennials™, and Best Medium Workplaces™ lists.OverviewThe Director, Regulatory Affairs will serve as the regulatory leader on ... identifying risks, interpreting regulations and providing guidance to ensure global regulatory compliance and the development of assigned programs in alignment with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders Job Summary: The Head of Regulatory Advertising and Promotion (RAAP) will lead and oversee all regulatory ... commercial goals. This role also involves managing a team of regulatory professionals, fostering collaboration across departments, and maintaining a proactive… more
- Merck & Co. (Rahway, NJ)
- …oncology, diabetes, respiratory & immunology, cardiology, pain & inflammation, reproduction, drug delivery or biotechnologyKnowledge of regulatory aspects of ... Job DescriptionThe Principal Scientist, Drug Discovery in our Research and Development Department...of 8 years industry or pharmaceutical research experience in drug discovery or preclinical research with a focus on… more
- Merck & Co. (Rahway, NJ)
- …in cell culture commercialization. The primary objective of the Biologics Drug Substance Commercialization (BDSC), Cell Culture Sciences department is to provide ... process validation, second generation process development and authoring of regulatory submissions.-Under the general scientific and administrative direction of the… more
- Merck & Co. (Rahway, NJ)
- …Prepare materials for program presentations for management review and regulatory submissions, ensuring clarity and thoroughness. Lead the implementation and/or ... within Device Development and with external suppliers. Understand and apply regulatory / compliance requirements relative to design controls and risk management… more
- Merck & Co. (Rahway, NJ)
- …In summary, our team enables the translation of preclinical candidates into non-oral drug products. We are seeking a highly motivated candidate for the position of ... Principal Scientist (R5) focused on developing parenteral drug products across a range of modalities (small molecule, peptides, proteins, antibody- drug … more
- Merck & Co. (Rahway, NJ)
- …combination products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The associate director will be a technical subject matter ... alignment with the company's business goals, and quality and regulatory compliance.-Essential Duties and Responsibilities:Utilize extensive experience in design… more
- Merck & Co. (Rahway, NJ)
- …in late stages of development, and working collaboratively with receiving sites, drug product partners, and Technical Product Leaders, regulatory and ... and combination products, with a focus on autoinjectors, prefilled syringes, and other drug delivery systems. The director will lead a team of engineers and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … drug development and commercialization.Ability to navigate evolving CDx-relevant regulatory guidelines and provide guidance and mentorship to junior CDx ... for any projects that definitively require a CDx for drug registration or for any project with CDPs containing...of CDx assays that are compliant with applicable global regulatory guidelines. Collaborates wtih Regulatory Affairs to… more
- Merck & Co. (Rahway, NJ)
- …as well as preparing for, management and follow up of regulatory inspections.Operational Quality Management:The Clinical Quality Operations Manager is accountable ... Preparation and Management:The CQOM is responsible for maintaining current regulatory inspection knowledge as it relates to Good Clinical Practice… more
- Lupin Pharmaceuticals (Coral Springs, FL)
- …the clinical and medical aspects of new respiratory medicines, including new drug or 505(b)(2) applications. This role involves strategic leadership in clinical ... target product profile (TPP) development, due diligence projects, and clinical- regulatory compliance. ResponsibilitiesEssential Duties and Responsibilities Clinical Development: Design… more
- Merck & Co. (Rahway, NJ)
- …teams manage studies to provide the safety and efficacy data required for regulatory approval of potential new drugs, vaccines and new indications for existing ... of clinical development, including study design, initiation, execution,-monitoring, analysis, regulatory reporting, publication, and presentation at national and international… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …has sufficient understanding of regulations and GCP requirements for drug development, advanced knowledge of Electronic Data Capture/related applications and ... he/she will possess advanced knowledge of clinical operations and relevant regulatory requirements. The individual will have advanced experience working on Phase… more
- Merck & Co. (Rahway, NJ)
- …device engineering, particularly in the design, manufacturing, and regulatory aspects of Autoinjectors and combination products.Primary Responsibilities:Technical ... and manufacturing of Autoinjectors, ensuring compliance with industry standards and regulatory requirements (eg, ISO 13485, FDA regulations). Actively seek out,… more
