- Merck & Co. (Upper Gwynedd, PA)
- …and identification of potential risks.Lead the development, communication, lifecycle management and review of the CMC Regulatory Strategy Document for assigned ... Job DescriptionGRACS CMC - Associate Principal Scientist, CMC, R4 - Pharm Pre-approval...regulatory leadership as needed in product in-license/due diligence review and product transition to the Post-Approval Pharm CMC… more
- TrackFive (Wichita, KS)
- …the Year, Largest Patient Impact, and Most Engaged Travel Associate .27978190EXPPLATJob Requirements Valid RN License BenefitsFlexCare's robust benefits package for ... accordance with the Los Angeles County Fair Chance Ordinance, FlexCare conducts a review of criminal history after a conditional offer of employment has been made… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …to address regulatory questions from Global Health Authorizes (HAs) during review of device submissionsIn collaboration with CDx lead work with Dx partners to ... centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… 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 EMA Competencies: Advanced ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… more
- Genmab (NJ)
- …like a fit? Then we would love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for ... portfolio of products. The lead may also be responsible for supporting various regulatory policy and/or intelligence deliverables. This role will be within Global … more
- Merck & Co. (Millsboro, DE)
- Job DescriptionOur company seeks to add an Associate Director. Veterinarian Services at our Millsboro, Delaware location. This position will have overall ... documentation, and other information as needed for annual reports to Federal regulatory agencies. Leadership for internal and external regulatory inspections… more
- Genmab (NJ)
- …like a fit? Then we would love to have you join us!The RoleThe Associate Director acts as a statistical expert supporting the clinical development of compounds as ... trial responsible statistician with responsibilities as described below. The Associate Director contributes to clinical development strategies and plans.Responsibilities:Compound/Indication… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. Associate Director, Medical Education - Oncology, is responsible for the strategic planning and ... strategic plan for assigned therapeutic area(s). These deliverables include development and review of compliant scientific exchange materials to be used in external… more
- Aequor (North Creek, WA)
- …(Required): Position Summary: We are seeking an experienced, highly motivated Research Associate to join our Manufacturing Science and Technology (MSAT) lab team in ... about issues, and developing custom part numbers Literature search and review to support understanding of experimental findings Data verification, sample management,… more
- Merck & Co. (Durham, NC)
- …commissioning, qualification through licensure and ramp up of facility.Author, review , and/or edit operations and technical documentation (Batch Records, SOPs, ... or similar)Experience with on-the-floor cGMP manufacturing and familiarity with regulatory requirements and Good Documentation Practices (GDP)Demonstrated ability to… more
- Eisai, Inc (Nutley, NJ)
- …price reporting, patient support, as well as other pharmaceutical regulatory counseling. Essential Functions: Provides proactive and day-to-day legal support, ... federal and state pricing-related laws and regulations, PhRMA Code and FDA regulatory guidelines.Serves as the legal representative for market access materials on… more
- Eisai, Inc (Exton, PA)
- …Development groups as well as with Facilities, Quality Assurance, Quality Control, Regulatory , and CMC Program Management departments.The Associate Director of ... your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and Downstream is...R&D and CMO personnel. Provide technical support and document review for phase III and PV at CMOs at… more
- Merck & Co. (Rahway, NJ)
- …the key quality representative attending and contributing to oversight and business review meetings with our company and contractor personnel to discuss projects, ... long-standing or significant issues affecting quality and efficiency.Interprets complex regulatory requirements for various audiences, reviews draft policies and… more
- Eisai, Inc (Nutley, NJ)
- …difference. If this is your profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible for the ... and MSL managers. Develop congress abstract tracker, assign MSL coverage, review MSL reporting responsibilities, collate and distribute Congress Report, execute pre-… more
- Twist BioScience (South San Francisco, CA)
- …process quality reports by collecting, analyzing, and summarizing information and trendsWrite/ review product quality documentationFollow regulatory and ISO 13485 ... The QC Associate II will be responsible for the implementation...stored, and distributed are manufactured in compliance with all Regulatory , Customer, and Twist requirements. In this position you… more
- Merck & Co. (Durham, NC)
- …Operations, Drug Delivery Systems and Devices within our Manufacturing Division ( Associate Director).-This role serves as a Virtual Plant Manager - responsible ... for all dealings between our Company and the External Partner, the Associate Director External Manufacturing Operations is accountable for establishing a strong… more
- Repligen (Waltham, MA)
- …the legal, investor relations, and senior finance teams to prepare and review quarterly earnings releases and related disclosures.Research and implement any changes ... changes in accounting policies and procedures to ensure compliance with regulatory and US GAAP standards.Provide technical accounting expertise for complex… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before database lock and quality check of data; Works… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …change controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and sponsor ... execute daily production schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager, and Manager.Oversee the hiring, development, and… more
- Merck & Co. (Durham, NC)
- …supplying quality product at a competitive cost consistent with our Company, Regulatory Agency, and State and Local code requirements for quality, good manufacturing ... procedures and business plan; receives guidance and oversight from Operations Associate Director and Director;Interprets client and/or customer needs and assesses… more
