- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …of medical review , providing expertise and guidance as lead Medical Reviewer on PMRT. Ensure appropriate early medical guidance and scientific direction is ... Associate Director (AD) is responsible for overseeing all activities related to Medical Review for their assigned Therapeutic Area (TA). The AD is accountable for… more
- Merck & Co. (Rahway, NJ)
- …business team with particular focus on promotional investment optimization. As a Senior Data Scientist, you need to have excellent quantitative and analytical skills ... and internal clients such as marketing brand leaders, center of excellence teams, senior management etc., to stay abreast of business trends, understand the business… more
- Aequor (Thousand Oaks, CA)
- …associated with cGMP equipment and facilities at Thousand Oaks (ATO). The senior engineer works in partnership with the automation, maintenance, project management, ... provide data to support business cases and long term strategy. The Senior Engineer role will provide direct engineering technical support as follows: Demonstrating… more
- Merck & Co. (Rahway, NJ)
- …with talented and dedicated colleagues while developing and expanding your career.The Senior Trial Initiation Specialist in Global Site Budgets and Payments will be ... guidance and work with stakeholders to prepare such guidance for review /approval.Identify and promote best practices. Adhere to SOPs, ethics and departmental… more
- Merck & Co. (Durham, NC)
- Job DescriptionThe Quality Control Senior Specialist plays a critical role in ensuring the quality of our products by managing laboratory data and overseeing the ... review of microbiological, chemical, and analytical data. This role...necessary, to support manufacturing processes.Responsibilities of the Quality Control Senior Specialist include leading routine testing of products, driving… more
- Aequor (Thousand Oaks, CA)
- …systems. Duties include purposeful presence on the floor, electronic batch record review , SOP revision & approval, work order approval, and quality approval of ... minor deviations and CAPA records. Responsibilities will include evaluation of compliance issues, providing recommendations, and assuring progress of quality records to completion. The Sr. Associate will also represent functional area for the Drug Substance… more
- Merck & Co. (KY)
- …attendance at product workshops and conferences, as well as consistent and ongoing review of our Company's promotional materials . - Utilizing analytical skills and ... tools to e ngage customers in quarterly business reviews regarding their vaccine contract to educate customers on the best ways to maximize their contract performance across the Company portfolio .-- - Assist ing customers with education to improve their… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Senior Director, Head Global PV Quality (DSI/DSE) reports to the Global Head ... that audit targets for tactical and strategic GVP audits are in place. Review risk assessment documents stemming from audit outcome to increase compliance within… more
- Merck & Co. (North Wales, PA)
- Job DescriptionPosition Description: Senior Study Manager - Epidemiology OperationsSupport the Lead Epi Scientists by providing overall operational support for study ... research studiesExecution, and close out of primary data collection, chart review , database, and molecular epidemiology studies in addition to other… more
- Aequor (Devers, TX)
- …audits EHS program implementation Job Description: Environmental, Health, and Safety Senior Specialist (EHS Senior Specialist) Onsite role--Local candidates only ... improve the effectiveness of workflows and processes (Learn and apply new concepts). Review and ensure accurate and complete resolution of issues as they arise and… more
- Merck & Co. (Durham, NC)
- …Services, Utilities and Validation. Position Description: GENERAL INFORMATION A Senior Engineer will provide organizational support and technical leadership for ... PQ and requalification activities for multiple pieces of equipment. The Senior Specialist will primarily support vaccine drug manufacturing via Validation program… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Are you ready to make a difference?The Position We are seeking an enthusiastic Senior Medical Doctor with a high degree of scientific acumen who is excited by ... will help develop multiple products. In doing so, the Senior Medical Director will work across different functional teams...as a leading member, or participant, at multiple internal review groups and utilize novel and creative methods to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …for a living. Are you ready to make a difference?The Position The Senior Medical Writer works closely with cross-functional project teams to manage preparation of ... the clinical development and regulatory requirements of a clinical program. Relationships The Senior Medical Writer reports to a Director of Medical Writing. The … more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction with key ... in the US and abroad, governmental, academic, community and industry organizations.The Senior Clinical Study Manager role is primarily a tactical study delivery… more
- Aequor (Thousand Oaks, CA)
- …management of staff. 2. May perform or oversee the following functions: a) Review and approve product MPsb) Approve process validation protocols and reports for Mfg. ... processes. c) Approve Environmental Characterization reports) Approve planned incidents) Represent QA on NPI team) Lead investigations) Lead plant audits, participate in site audits) Approve change-over completion) May perform work of QA Specialist… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …study problems.Responsibilities- Protocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, ... low to medium complexity studies including study design, protocol development, CRF review , SAP development, analysis files development, data surveillance review ,… more
- Daiichi Sankyo, Inc. (Basking Ridge, 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. (Basking Ridge, NJ)
- …monitoring activities and results.Conduct field-based (live) monitoring, records review , and data-based monitoringData analytics Maintain/revise current monitoring ... with the various business functions across the business to design and review business-led monitoring activities as part of their overall responsibilities and, if… more
- Eisai, Inc (NJ)
- …If this is your profile, we want to hear from you. Job Summary The Senior Manager, Medical Writing will be the designated Lead Medical Writer for approximately 3-4 ... Global Investigator Brochures (GIB) and annual regulatory reportsPrepare and review marketing application submission documentsAt the Director's discretion, may… more
- Eisai, Inc (Nutley, NJ)
- …for guidance and consultancy on system validation. Support computer system audits for review of SDLC and data integrity controls. Review CAPA and verification ... of CAPAs of system audits. Support health authority audits/inspections for inspection readiness. Requirements Bachelor's degree in associated functional disciplines including IT, Data Sciences and others.Software development familiarity with both Agile and… more
