- Merck & Co. (Rahway, NJ)
- …in the design, manufacturing, verification, validation and associated quality and regulatory aspects of combination products.The incumbent must be able to lead ... full integration of the device development activities with the clinical, regulatory , formulation, commercial and other key company functions.Lead the Device… more
- Merck & Co. (North Wales, PA)
- … analysis , and interpretation posed by the clinical monitors, regulatory agencies, or investigators.-10. Responsible for ensuring the accuracy of Statistical ... work experience.Preferred Experience and Skills: Broader scientific leadership in design and analysis of clinical trials; Experience with regulatory filing for… more
- Formation Bio (New York, NY)
- …with regulatory submissions involving imaging endpoints or AI-based image analysis tools Experience with multi-modal imaging fusion and analysis (combining ... patient outcomes. You'll develop state-of-the-art models for automated image analysis , disease progression monitoring, and treatment response assessment. Working… more
- Merck & Co. (Rahway, NJ)
- …formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products ... product technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory … more
- Merck & Co. (Rahway, NJ)
- … 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. (North Wales, PA)
- …art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for ... work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs.--The AVP provides leadership and direction through senior-level and… more
- Aequor (Thousand Oaks, CA)
- …or Chemical Engineering, with proven experience in simulation, modeling, and data analysis within a GMP-regulated environment. They are proficient in Python, MATLAB, ... applied to physical systems. The candidate holds either a PhD with no required industry experience, a Master's degree...the way manages and utilizes data to enhance data analysis and decision making within the organization. We are… 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 ... degree.8 years with a master's degree.4 years with a PhD .Required-Skills:Technical Expertise: Proficient in the purification of biological molecules, including… 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 ... pharmacokinetics (popPK), PK/PD models, exposure response (ER) models, model-based meta- analysis (MBMA), clinical trial simulations (CTS) and disease progression… 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
- Genmab (NJ)
- …and approve any amendments, corrections, and updates of data packagesSupport regulatory submission/filing activitiesRequirements: Master's or PhD in a ... methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication level discussionsActs as a role… more
- Insmed Incorporated (San Diego, CA)
- …hands-on laboratory work, analytical procedure optimization, troubleshooting, and data analysis and collaboration with all process development teams to ensure ... technical issues. Contributes to method qualification and validation according to regulatory guidelines such as ICH, FDA, and cGMP, evaluating method characteristics… more
- Merck & Co. (Boston, MA)
- …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)
- …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)
- …mentorship to other clinical scientists. Core Skills Solid knowledge of clinical research regulatory requirements (e . g . , GCP and ICH) Ability to manage ... clinical drug development, project management, and/or medical field experience OR PhD /PharmD Degree Degree in life sciences, preferred . ~15% TravelCurrent Employees… 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)
- …of Critical Quality Attributes/QbD/DOE principles as well as data analysis and statistics for setting specifications.Extensive experience with bioprocess derived ... and transfer using immunoassay techniques.Extensive knowledge and experience with regulatory guidance and industrial standards of control strategy for residual… more
- Merck & Co. (Rahway, NJ)
- …of clinical development, as well as process characterization and regulatory filings for successful commercialization.Improve upstream processes by increasing ... prioritization, and problem-solving skills.Stay updated on the scientific and regulatory landscape; contribute scientifically and build your reputation through… more
- Merck & Co. (North Wales, PA)
- …engagements. This includes the ability to:Solid knowledge of clinical research regulatory requirements (eg, GCP and ICH)Ability to manage multiple competing ... drug development, project management, and/or medical field experience OR PhD /PharmD Degree in life sciences, preferred.Ideal candidate would have:Experience in… more
- Genmab (NJ)
- …the CSR Attend operational and steering committee meetings, as applicableSupport regulatory submission/filing activitiesRequirements:MS / PhD or equivalent in a ... methodologies that may support innovation and improve efficienciesEngage with regulatory authorities on compound/indication level discussionsActs as a role… more
