- Merck & Co. (Fort Wayne, IN)
- Job DescriptionThe- Senior Vaccine Customer Representative (VCR) supports customers by providing clinical information on our Company's vaccines, as well as education ... at product workshops and conferences, as well as consistent and ongoing review of our Company's promotional materials.Utilizing analytical skills and tools to engage… more
- Merck & Co. (North Wales, PA)
- Job DescriptionJob Description:Our Biomarker Operations team is seeking a Senior Scientist in Biomarker Policy to manage biomarker samples and ensure compliant ... experience, preferably with clinical trial specimensInformed consent authoring and/or review experience within a relevant biopharmaceutics industryFamiliarity with clinical… more
- Aequor (West Greenwich, RI)
- …procedures and products follow cGMP practices and other applicable regulations. Performs review and approval of cGMP processes, procedures, documents and records. ... Review logbooks, batch records, attachments, work orders, and other GMP documentation. Ensure that deviations from established procedures are documented per… more
- Merck & Co. (North Wales, PA)
- …scientist on the clinical trial team.Leading medical monitoring team in review and interpretation of clinical data/medical protocol deviations in collaborations with ... the Clinical Director. Other responsibilities include: Collaborating cross-functionally in the development of Protocol and related study materials (eg, ICF documents / amendments); Partners with the Study Manager on study deliverables.Ensuring CRF design… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …factors based on the project or service delivery and coordinates legal review of finalized contract Understands and applies risk management practices: Ensures ... departmental project and QA requirements are fulfilled and adhered to Incorporates quality systems into all stages of the project/lifecycle to ensure deliverables meet quality requirements Physical Requirements 10-20% overnight travel required. Qualifications… more
- Merck & Co. (Lenexa, KS)
- …tactical business alignment and timely decision makingParticipate in monthly Livestock Review meeting with BU leadership, finance, supply chain, and manufacturing ... leadershipWork with supply chain to ensure adequate product supplyDevelop leadership and influencing skills to organize and direct projects in a matrix team environment without formal reporting relationshipsProvide analytical support to the commercial team, as… more
- Genmab (Plainsboro, NJ)
- …As part of our expanding US Medical Affairs (USMA) team, Genmab is seeking a Senior Director, USMA Solid Tumor Portfolio. This role will report to the VP/Head of US ... investigator-sponsored trial program for solid tumor assets/disease and participates in the review of all US ISTsEnsures the delivery of timely, accurate and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …system rejections or missing/incomplete data daily- Analyze various payment files; calculate, review , verify and post a variety of complex payroll data such as ... Analyze files submitted for completeness, audit updates to the payroll register, review state tax information for accuracy and appropriate processing, and establish… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization ... the UAT (User Acceptance Testing) and CCG (CRF Completion Guidelines) review - Conducts clinical data review per Integrated Data Review Plan- Accountable for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …post trial information on required public forums (eg.clinicaltrials.gov).- Under supervision, review and document CRO-generated reports, such as site monitoring trip ... to the attention of the supervisor.Compile and maintain a monitoring review spreadsheet.Compile and maintain CRO Oversight Monitoring (CROOM) visit outputAnalyze… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …personal development. Are you ready to maximize your potential with us? The Position The " Senior Architect - Data Management & AI" is a technical leader with a deep ... development methodologies Excellent technical writing, document organization, technical document review and analytical thinking skills Excellent presentation skills with… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization ... (User Acceptance Testing) and CCG (CRF Completion Guidelines) reviewConducts clinical data review per Integrated Data Review PlanAccountable for the assessment… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …CMC regulatory experienceSuccessful track record in preparation, management of review and approval of NDA/MAA/BLA with FDA and EMACompetencies:Advanced knowledge ... of regulations/guidance documents with strong technical knowledge based upon academic training and job experience.Strong oral and writing skill. Able to write regulatory documents in highly complex technical areas.TravelAbility to travel up to 10%, Global… more
- Aequor (Thousand Oaks, CA)
- …in labeling and Regulatory document management. Experience in promotional review and approval process. Previous experience is preferred. Performance Factors: ... 1. Relationships with Others: The employee works effectively and relates well with others including superiors, colleagues, and individuals inside and outside the Company. The employee exhibits a professional manner in dealing with others and works, to maintain… more
- Genmab (Plainsboro, NJ)
- …as relevant to support optimized labeling. Ensure proper development, review , approval, implementation, maintenance, distribution and tracking of labeling documents ... according to internal SOPs and external regulatory requirements.Prepares submission-ready labeling documents; Maintains and tracks labeling documents in the electronic system as appropriate.Participates in the development and maintenance of SOPs, work… more
- Aequor (West Greenwich, RI)
- …procedures and products follow cGMP practices and other applicable regulations. Performs review and approval of cGMP processes, procedures, documents and records. ... Review logbooks, batch records, attachments, work orders, and other GMP documentation. Ensure that deviations from established procedures are documented per… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to ensure that FDA receives timely and quality submissions, shortening the review process and leading to successful approval of pharmaceutical applications for the ... company's growth, thereby accomplishing corporate goals.The role will be accountable for coordinating, mentoring, and providing guidance to direct reports (US RA strategists) across the alliance products to produce robust, innovative and cohesive regulatory… more
- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.The Role & Department As a Senior Programming Associate or Programming Manager, you will be in the Statistical ... process by applying the appropriate measures (writing of code, review of code/deliverable).Supports submissions by ensuring programming deliverables are consistent… more
- Merck & Co. (North Wales, PA)
- …data to analyze the safety and efficacy claims of potential medical breakthroughs. Review the quality and reliability of clinical studies using deep scientific ... knowledge, statistical analysis and high-quality data to support decision making in clinical trials.Support statistical programming activities for Early Oncology clinical development projects.Responsible for the development and execution of statistical… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …for all staff members, to include preparing and conducting performance evaluations. Review and ensure the reliability of technical data related to formulation, ... process, analysis, and stability monitoring for new products and processes to be included in regulatory submissions.Coordinate and communicate with cross function team members throughout Exela and customers.Coordinate activities of the Technical Services staff… more
