- Merck & Co. (North Wales, PA)
- …not limited to) the implementation of primary data collection, chart review /survey, database studies, health economic model development and adaptations, dossiers, ... study execution through close-out of primary data collection, chart review , and database studies in addition to other activity...separation date and are offered a position within the salary and geographical parameters as set forth in the… more
- Merck & Co. (Rahway, NJ)
- …and/or subsidiaries for all applications and submissions.Responsible for regulatory review and final approval of all submissions and associated ... coordinates cross-functional regulatory support for development programs and marketed products. Review and provide final approval of local registration study… more
- Merck & Co. (Rahway, NJ)
- …is: Accountable for HHDDA Taxonomy, Demand Management Tool & Project Approval & Review (PAR): Acting on behalf of Human Health Operating Committee (HHOC) and HHDDA ... and synthesize inputs.Maintain a taxonomy playbook complete with structured business review templates to facilitate tradeoffs / reprioritization discussions with BU… more
- Merck & Co. (Durham, NC)
- …direct in-line Quality support for all compliance and environmental monitoring matters, review of atypical events including accessing product impact for EM events, ... providing Quality oversight to alarm events during processing, review and approval of incursions, review and...separation date and are offered a position within the salary and geographical parameters as set forth in the… more
- Merck & Co. (North Wales, PA)
- …and regulatory submissions including assisting in preparing submissions, protocol review , and conducting research on regulatory guidance's or competitive ... or take the lead in tracking, authoring, shepherding and/or review of responses to Agency requests.Implements strategy to develop...separation date and are offered a position within the salary and geographical parameters as set forth in the… more
- Merck & Co. (Rahway, NJ)
- …and/or support batch processing readiness and execution activities. Prepare, review , and/or approve GMP Documentation as appropriate. Author/Approve Standard ... on best practices. Author lessons learnt through after action review summaries or other reports to capture knowledge gained....separation date and are offered a position within the salary and geographical parameters as set forth in the… more
- Catalent (Philadelphia, PA)
- …Quality Assurance Document Control individual is responsible in preparing customer files, review and approve batch records, and release batch records and finished ... primary liaison to our customer's quality assurance groups for batch record review and release. The Quality Assurance Document Control manages the communication… more
- Insmed Incorporated (Bridgewater, NJ)
- …from regulatory authority or EC/IRBs.Provide medical feedback for activities related to review of data for interim analysis or blinded data reviews.Production of ... eg MACE, Potential events related to metabolite, Liver enzymes. Review of mortality cases, evaluation of CIOMS, production of...and external market and internal value when determining a salary level for potential new employees. The base … more
- Insmed Incorporated (Bridgewater, NJ)
- …active role in CSV activities including, but not limited to, review and approval of relevant CSV documents.ResponsibilitiesManages direct reports including project ... and managing spend for lab consumable purchases. This will include authorship, review , and approval of technical documents such as qualification protocols and SOPs… more
- Merck & Co. (Rahway, NJ)
- …AH enterprise application architecture.Design and chair the Animal Health Architecture Review Board (AH-ARB) to facilitate the governance process for architecture ... managing architecture governance processes, such as leading an Architecture Review Board (ARB).Experience integrating legacy systems with modern technologies to… more
- Merck & Co. (North Wales, PA)
- …flow to/from internal and external service providers, joint venture document review and clearance and independent manuscript review .Tracking and reporting ... separation date and are offered a position within the salary and geographical parameters as set forth in the...is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect… more
- Merck & Co. (Rahway, NJ)
- …in Oncology or Hospital/SpecialtyExperience in company end-to-end medical/legal (Promotional Review Team) review and delivery processes.Experience with ... separation date and are offered a position within the salary and geographical parameters as set forth in the...is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect… more
- Catalent (PA)
- …change orders, and SOWs.Participate in New Product Evaluation (NPE) and deal review meetings and support the site selection process.Hold and/or participate in ... technical review meetings with prospective clients and current partners to...paid time off annually + 8 paid holidays Competitive salary with yearly bonus potential Community engagement and green… more
- Merck & Co. (Boston, MA)
- …TMed at governance for the Immunology portfolio (discovery therapeutic area review , early and late-stage clinical governance), and fully supportive of external-based ... as the deep subject matter expertise in Translational Immunology.Immunology Discovery Review core member.Represent TMed at core governance (early and late… more
- Merck & Co. (Rahway, NJ)
- …governance for the Cardiovascular & Respiratory portfolio (discovery therapeutic area review , early and late-stage clinical governance), and fully supportive of ... subject matter expertise in Translational Cardiovascular & Respiratory Medicine CMD Discovery Review core member Represent TMed at core governance (early and late… more
- Lundbeck (Chicago, IL)
- …to measure and evaluate the effectiveness of training and provides metrics for management review Acts as a point of contact for sales and marketing teams regarding ... on various advisory committees Oversees Veeva Vault Submissions for internal review process with Medical and Legal teams Manages relationships with external… more
- Merck & Co. (Millsboro, DE)
- …with Guidance from the QC Manager, ensures product/process quality through the review of GMP documentation and performs activities to ensure the efficient testing ... departments in receipt, distribution, scheduling of QC tests, and review and release of antigen and seed batches. The...separation date and are offered a position within the salary and geographical parameters as set forth in the… more
- Merck & Co. (Rahway, NJ)
- …guidance and work with stakeholders to prepare such guidance for review /approval.Identify and promote best practices. Adhere to SOPs, ethics and departmental ... separation date and are offered a position within the salary and geographical parameters as set forth in the...is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect… more
- Merck & Co. (Rahway, NJ)
- …for our Biologics pipeline. As part of this role, they will author and review CMC sections of regulatory submissions and associated source technical reports and risk ... separation date and are offered a position within the salary and geographical parameters as set forth in the...is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect… more
- Merck & Co. (Rahway, NJ)
- …submissions for assigned products.- Leading cross-functional teams to develop, review and approve Core and Local Labeling documents.- Recommending strategies ... separation date and are offered a position within the salary and geographical parameters as set forth in the...is required to provide a reasonable estimate of the salary range for this job. Final determinations with respect… more
