- Merck & Co. (Rahway, NJ)
- …device and combination products, guiding cross-functional teams to ensure regulatory compliance throughout development and commercialization. Mentor team ... Combinations CMC (Chemistry, Manufacturing & Controls), you will report to the Director of Device Regulatory Affairs for Autoinjector Development Programs. You… more
- Merck & Co. (Rahway, NJ)
- …degree with 12+ years of industry experience, including regulatory and/or compliance area and experience with process management in a regulated ... maintaining efficient, effective, and compliant business standards, process maps, and risk management for global processes across Global Regulatory Affairs and… more
- Merck & Co. (Rahway, NJ)
- …Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases of product development to ... portfolio. Within Biologics and Biopharmaceutics, the large molecule product development Director will influence the strategy, lead activities, and develop a team… more
- Merck & Co. (Rahway, NJ)
- …site, region, and global business partners to drive prioritization of regulatory compliance , continuous performance improvement, and integration of EHS ... applying regulatory frameworks and keeping abreast of the changing regulatory landscape.Strong leadership, change execution, and financial management skills… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionJob Overview:-We are seeking a highly qualified and experienced Associate Director in Data Management to lead our data management team in ... role.Expertise in Prelude software or similar dedicated data management applications.Comprehensive understanding of regulatory regulations and company… more
- Merck & Co. (Rahway, NJ)
- …development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced ... therapeutic areas and modalities to drive portfolio impact from discovery through life-cycle management . The team is externally visible and continues to be at the… more
- Merck & Co. (Rahway, NJ)
- …pharmacokinetics modeling software (eg, Simcyp, GastroPlus) is highly desired.Experience in regulatory compliance expectations across all phases of product ... compliance mindset.Essential Knowledge, Duties & Responsibilities for the Director Include:Biopharmaceutics expertise supporting delivery of small molecule, peptides… more
- Merck & Co. (Rahway, NJ)
- …chemical and biochemical processes, parenteral, oral, and specialty dosage formulations.- The director should be well engaged with regulatory and industry trends ... R&D and DSCS. --The candidate will have experience in an innovative analytical/ regulatory /GMP environment.The Director will effectively team with the SMAR&D… more
- Merck & Co. (Rahway, NJ)
- …the Research & Development pipeline and realize its full potential. The Associate Director is expected to provide project management leadership and drive ... Project Manager is part of Global Project and Alliance Management (GPAM) which sits in the Research & Division...our company. - Position Description/Summary: - The GPAM Associate Director , Project Manager, is a core member of Early… more
- Merck & Co. (Rahway, NJ)
- …transformation that reflects the evolving demands of our business. Risk Management :-Proactively identify potential technical, operational, and regulatory ... Job DescriptionWe are seeking a visionary Executive Director to lead our End-to-End Technical Leader organization...the lifecycle of product franchises, (2) project and portfolio management support across pipeline and supply, and (3) the… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionR5 - Director - Pharmacometrics, Quantitative Pharmacology and PharmacometricsT he (remote) position is only applicable for those that are not within ... development (MIDD) to routinely enable efficient drug discovery/development and/or regulatory decisions. The Pharmacometrics group within QP2 brings an experienced… more
- Merck & Co. (Rahway, NJ)
- …cross-functional development teams to enable pipeline decisions. -The Executive Director , Biologics Analytical Research and Development (B-AR&D) is responsible for ... of Biologics programs (approximately 10-15 programs), and leading multiple Director lead Development teams, overall approximately 40-50 scientists. Strategic… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Executive Director , Global Pharma Communications is responsible for leading, developing and executing US and global communications strategies and ... Associate Vice President, Human Health and Manufacturing Communications, the Executive Director , Global Pharma Communications is responsible for the development of… more
- Merck & Co. (Rahway, NJ)
- …& connectivity between functions supporting pipeline (ie clinical development, Compound Management Coordination , supply chain, & human health), and balancing needs ... Global Clinical Supply Planning program representative) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines,-… more
- Merck & Co. (Rahway, NJ)
- Job Description Director -QP2-IO We are seeking an experienced talented scientist to join the Quantitative Pharmacology and Pharmacometrics - Immune/Oncology ... (QP2-IO) team in the role of Director . QP2-IO team is part of the Global Clinical...and survival. A Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology,… more
- Merck & Co. (Rahway, NJ)
- …expertise in cell culture and fermentation sciences, leadership and project management , and regulatory knowledge in the Pharmaceutical/Biotech industry OR ... expertise in cell culture and fermentation sciences, leadership and project management , and regulatory knowledge in the Pharmaceutical/Biotech industry ORPh.D.… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Director of Biologics Potency in Analytical Research & Development is responsible for providing strategic and technical leadership for a portion ... talent development, and partnering to build a culture of innovation and inclusion.-The Director reports to the Executive Director , Cell Based Sciences and will… more
- Merck & Co. (Rahway, NJ)
- …adhere to industry regulations and guidelines, working closely with legal and regulatory teams to manage and communicate compliance issues. Drive our ... management . Strong understanding of pharmaceutical industry regulations and compliance requirements. Demonstrated deep understanding of the business and the… more
- Merck & Co. (Rahway, NJ)
- …Scientist is a senior scientific role tasked with working closely with the group Director to define group strategy and to lead a team of scientists in solving ... program deadlines.Authoring and reviewing internal technical reports, sections of regulatory filings (eg, IND, BLA) and external scientific publications.Experience… more
- CIBC (New York, NY)
- …coordination of RCM activities, and ensuring alignment with industry standards and the Bank's Regulatory Compliance Management Policy. At CIBC we enable the ... the Swap Dealer Chief Compliance Officer, the Director , RCM Portfolio Management is responsible for...within CGRA. **Who You Are:** + Extensive experience of regulatory compliance management activities such… more
