- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... projects.- Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis… more
- Merck & Co. (North Wales, PA)
- … requirements, internal standard operating procedures, and external regulatory requirements.Evaluates appropriateness of available software for planned analyses ... analysis , and interpretation posed by the clinical monitors, regulatory agencies, and/or investigators.-Is responsible for planning and ensuring the accuracy… more
- Merck & Co. (Rahway, NJ)
- …manufacturing sites, process validation, manufacturing investigations and trend analysis , process enhancements, next generation process development, and authoring ... of regulatory submissions.Under the general scientific and administrative department direction...Provides technical leadership for the design of experiments, data analysis and interpretation, as well as mentoring of junior… more
- Merck & Co. (Durham, NC)
- …Drivers (Oncology, Vaccines, Select Specialty Areas, Animal Health) While Optimizing Our Base Business ) Adapt - Develop Our People, Culture and Business Model to ... solutions. Off-shift and weekend coverage will be required at times based on business unit needs and specific assignments.Specific assignments may be focused in one… more
- Merck & Co. (South San Francisco, CA)
- …and review, conducting hazard assessments, incident investigations using root cause analysis techniques, environmental regulatory field analysis , ... - Integrates EHS programs into daily operations to assure regulatory compliance, achieves continuous performance improvement, meeting EHS performance objectives.… more
- Merck & Co. (Rahway, NJ)
- …products and processes are developed in accordance with applicable regulatory , quality, company, and customer requirements.-This position will lead cross-functional ... integration of the device development activities with the clinical, regulatory , formulation, commercial and other key company functions.Represent Device Development… more
- Merck & Co. (Rahway, NJ)
- …indications to pursue and subsequent study design, initiation, execution, monitoring, analysis , regulatory filing, and publication. Specifically, The Senior ... and Investigational New Drug applications.Providing clinical development support of business development assessments of external opportunities to grow the Immunology… more
- Merck & Co. (Rahway, NJ)
- …in a timely manner.-Collects, reviews, and monitors required regulatory documentation for study start-up, study-maintenance and study close-out.Communicates ... on issues related to protocol conduct,-recruitment, retention, protocol deviations, regulatory documentation, site-audits/inspections and overall site performance.Identifies, assesses and… more
- Merck & Co. (Rahway, NJ)
- …including proportional hazards models.Maintaining a comprehensive understanding of global regulatory expectations for small molecules and biologics in Oncology, ... authoring regulatory documents (investigational new drugs/INDs, clinical study reports (CSRs), clinical trial applications (CTDs)), and representing our team at … 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 ... driving pipeline impact: population pharmacokinetics (PK) and pharmacodynamics (PD) analysis , model-based meta- analysis (MBMA), clinical trial simulations (CTS),… more
- Merck & Co. (Rahway, NJ)
- …different stages of clinical development, 2) process characterization and regulatory filings for successful commercializationAdvance upstream processes by improving ... organizational, prioritization and problem-solving skillsStay abreast of scientific and regulatory landscape; actively present (premier conferences), publish (peer-reviewed journals)… more
- Merck & Co. (Rahway, NJ)
- …by Design (QbD) and Design of Experiments (DOE) principles as well as data analysis and statistics Working knowledge of Regulatory Good Practices (GxP) with ... automated liquid handling platforms for parallel experimentation Experience in analysis of biologics or other pharmaceutically relevant entities using separation… more
- Merck & Co. (Rahway, NJ)
- …background and experience in separations scienceExtensive experience with UPLC/HPLC analysis of biologics (eg SEC, RP, IEX)Extensive experience with process- ... understanding of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics for setting specificationsAbility to design, execute and/or… more
- Merck & Co. (Durham, NC)
- …with our incredibly high standards of quality and meets all regulatory requirements.- Partnering across our internal manufacturing facilities, external contract ... in support of manufacturingScheduling and submitting material samples for analysis to internal and external laboratoriesCoordinating, reviewing and submitting… more
- Merck & Co. (Rahway, NJ)
- …understanding of the external healthcare environment and our Company's internal business , with a focus on Immunology and cross-therapeutic area capabilities. ... Partnering with key stakeholders, individual will benchmark competitor clinical data, business models and capabilities to develop insights and recommendations that… 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 ... pharmacokinetics (popPK), PK/PD models, exposure response (ER) models, model-based meta- analysis (MBMA), clinical trial simulations (CTS) and disease progression… more
- Merck & Co. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... Accountability predominantly includes the development and execution of statistical analysis and reporting deliverables (eg safety and efficacy analysis… more
- Merck & Co. (Rahway, NJ)
- …assets and systems.Collaborate with cross-functional teams, including IT, OT, and business stakeholders, to assess security risks and design appropriate security ... controls.Conduct in-depth analysis of our Operational Technology environment, identifying potential vulnerabilities and recommending mitigation strategies.Define and… more
- Merck & Co. (North Wales, PA)
- …with internal and external stakeholders including Statistics, Clinical Research, Regulatory , Observational Research, Clinical Safety and PK/PD Modeling and ... skillsSuperior knowledge and significant experience in setting strategy and developing analysis and reporting deliverables for Research & Development projects (data,… more
- Merck & Co. (Rahway, NJ)
- …Marketing - Director, Parasiticide Portfolio MarketingThe Companion Animal (CA) Business unit leads strategy development and execution across markets throughout ... pipeline of new products and initiatives providing customer benefits and driving business growth.A range of our current portfolio are leaders within their respective… more
