- Merck & Co. (Rahway, NJ)
- …design controls and risk managementLed and managed development of DHF (design history file ) deliverables for medical devicesRecognized as a subject matter expert ... Job descriptionThis position will be responsible for leading and implementing medical device and combination product design controls for both new products… more
- Merck & Co. (Rahway, NJ)
- …and robust manufacturing processes through process characterization, technology transfer, validation, filing and supply support of late-stage projects in the small ... development such as chemical reactions, work-up, and crystallizationExperience leading file authoring, validation planning and executionExperience guiding internal/external technical… more
- Genmab (NJ)
- …amendments, corrections, and updates of data packagesSupport regulatory submission/ filing activitiesExperience:Master's or PhD in a statistical discipline8+ years ... experience in dealing with Health authorities such as discussions/negotiations in filing strategiesExperience working with SDTM, ADaM, eSUB, and CDISC requirements… more
- AUROBINDO (Dayton, OH)
- …ResponsibilitiesSenior Scientist with previous industrial experience developing and filing generic drug dosage forms (orals/liquids)Ability to develop the ... Search on assigned Projects.Thorough understanding of the ANDA (and preferably NDA) filing process in line with QbD elements in generic product developmentExperience… more
- Eisai, Inc (Nutley, NJ)
- At Eisai, satisfying unmet medical needs and increasing the benefits healthcare provides to patients, their families, and caregivers is Eisai's human health care ... minutes and action itemsPerforms eTMF assist with set-up requests andAssists with filing and archiving project documentation in the eTMF within the defined… more
- Merck & Co. (South San Francisco, CA)
- …support for programs through the worldwide marketing application filing including supportive registration documents and presentationsProvide clear, timely ... applicable.We offer a comprehensive package of benefits.- Available benefits include medical , dental, vision healthcare and other insurance benefits (for employee… more
- Merck & Co. (Rahway, NJ)
- …and knowledge of product and process development in the (bio)pharmaceutical and medical device industries to set tactical and strategic direction on programs to ... launch. The ideal candidate will possess extensive knowledge in medical device engineering, particularly in the design, manufacturing, verification, validation… more
- Merck & Co. (Rahway, NJ)
- …project management in the scale-up, development, commercialization, and transfer of medical devices and combination products, with a focus on autoinjectors, ... in the development, commercialization, and transfer and sustained launch of medical devices and combination products globally.Develop and execute strategic plans for… more
- Merck & Co. (Rahway, NJ)
- …robust scientific methodology we collaborate to discover and develop the next medical breakthrough. Our Company's success is backed by ethical integrity, forward ... novel innovations during drug product development to enable best science at first filing for parenteral development processes for human health while ensuing a phase… more
- Merck & Co. (Rahway, NJ)
- …to ensure manufacturing readiness aligns with regulatory strategy and filing timelinesEducation: Bachelor's Degree in (Bio)Chemical Engineering or related discipline ... applicable.We offer a comprehensive package of benefits.- Available benefits include medical , dental, vision healthcare and other insurance benefits (for employee… more
- Merck & Co. (North Wales, PA)
- …of worldwide regulatory submissions.This position involves interaction with Medical , Data Coordination, Statistical Programming, Research Laboratories scientists and ... in design and analysis of clinical trials; Experience with regulatory filing for approval of drug/vaccine products; Prior experiences with immunology clinical… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …and partner sites.Provide technical support and leadership during Agency Inspections, filing of Submissions, and IRs.Maintain global master batch record and ... they feel valued and supported every step of the way. Highlights include medical , dental, and vision insurance as well as a 401(k)-retirement plan with company… more
- Genmab (NJ)
- …Attend operational and steering committee meetings, as applicableSupport regulatory submission/ filing activitiesRequirements:MS / PhD or equivalent in a statistical ... Plan: 100% match on the first 6% of contributionsHealth Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insuranceVoluntary Plans:… more
- Genmab (NJ)
- …consistency across trialsResponsible for keeping proper documentation and filing to eTMFProvide sponsor oversight of vendor programming activitiesSupport ... Plan: 100% match on the first 6% of contributionsHealth Benefits: Two medical plan options (including HDHP with HSA), dental, and vision insuranceVoluntary Plans:… more
- BioAgilytix (San Diego, CA)
- …uses standard office equipment such as computers, phones, photocopiers, and filing cabinetsPhysical DemandsAbility to work in an upright and/or stationary position ... (HDHP with HSA; PPO), Dental Insurance, Vision Insurance, Flexible Spending Account ( medical ; dependent care), Short Term Disability | Long Term Disability Life… more
- BioAgilytix (Durham, NC)
- …uses standard office equipment such as computers, phones, photocopiers, and filing cabinetsPhysical Demands:Ability to work in an upright and/or stationary position ... (HDHP with HSA; PPO), Dental Insurance, Vision Insurance, Flexible Spending Account ( medical ; dependent care), Short Term Disability | Long Term Disability Life… more
- AUROBINDO (Durham, NC)
- …resumes, conducting phone screens, and interviewing.Assist with benefits administration including medical , dental, vision, COBRA and 401(k), health and welfare open ... company policies and federal, state, and local employment laws. File employee records while maintaining confidentiality.Support benefits enrollment, changes, and… more
- Merck & Co. (Rahway, NJ)
- …and/or epidemiologists within BARDS, as well as stakeholders in data management, medical writing, and clinical operations to gather and document requirements for ... trial decision-making, regulatory requests, clinical study reports, and new drug application filing . Produce SAS data transport files and program text files for… more
- Genmab (NJ)
- …Programming Manager will support the Data Management, Statistics, Drug Safety, Medical , Clinical Pharmacology and Biomarker functions with the above by developing ... answers to in-house questions related to data quality, safety monitoring, medical questions etc.Performs sponsor oversight of programming activities on the DM… more
- Repligen (Rancho Dominguez, CA)
- …initiatives.The ideal candidate has a strong background in biopharma or medical device manufacturing, with deep expertise in Tangential Flow Filtration (TFF) ... required. 8-10+ years of experience in life sciences, pharmaceuticals, medical devices, or biologics manufacturing is highly desirable. Hands-on experience… more
