- Merck & Co. (Upper Gwynedd, PA)
- … regulatory issues to GRACS CMC management, as neededDemonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the ... Job DescriptionGRACS CMC - Associate Principal Scientist, CMC, R4 - Pharm Pre-approval...Regulatory Compliance, Microbiology, Molecular Microbiology, Pharmaceutical Process Development, Regulatory Affairs Compliance, Regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …including working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub ... applications/supplements & variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic ... products.Responsibilities: CDx development : Provide critical strategic and tactical regulatory guidance for CDx/IVD development and CDx submission plan for… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. The Associate Director (AD), Global Medical Affairs Training and Education is responsible ... & International). Eisai Salary Transparency Language:The base salary range for the Associate Director , Global Medical Affairs Training and Education… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole SummaryUnder the guidance of a senior leader, an Associate Principal Scientist/ Associate Director , has primary responsibility for ... is expected to work cross-functionally with clinical development, medical affairs , biostatistics, market access, commercial and country affiliates. The incumbent… more
- ADMA BIOMANUFACTURING LLC (Boca Raton, FL)
- …then consider ADMA Biologics. We currently have an exciting opportunity available for an Associate Director , Regulatory Affairs - Plasma Services in ... Boca Raton, Florida! The Associate Director , Regulatory Affairs - Plasma Services is responsible for the regulatory compliance of the Plasma Services… more
- Insmed Incorporated (San Diego, CA)
- …lead on a PDT as required by the business.ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team to take ... also key duties. Collaboration with R&D, Process Development, Quality Control, and Regulatory Affairs is essential, as is facilitating technology transfers and… more
- Eisai, Inc (Nutley, NJ)
- …make a difference. If this is your profile, we want to hear from you. Associate Director , Medical Education - Oncology, is responsible for the strategic planning ... & ManagementEisai Salary Transparency Language:The base salary range for the Associate Director , Medical Education - Oncology is from :162,600-213,400Under… more
- Genmab (NJ)
- …to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading the development and ... and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report to...Affairs (GRA) and will report to the Sr. Director , Labeling, Policy and Intelligence. The position may be… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …pull you in? Are you ready to experiment with us? The Position The Associate Director Consumer Marketing will be responsible for supporting the development and ... in alignment with overall business objectives. Relationships Reports to the Sr. Director , Wegovy Consumer Marketing . C ollaborates with sales, marketing, training,… more
- Merck & Co. (Rahway, NJ)
- …Work closely with a cross-functional group of experts in commercialization, regulatory affairs , statistics, and manufacturing to manage clinical development ... including development strategy, study design, initiation, execution, monitoring, analysis, regulatory reporting, and publication.Specifically, the Senior Director … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …design pull you in? Are you ready to experiment with us? The Position The Associate Director of Nephrology Key Opinion Leader Marketing will be a pivotal driver ... affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , other relevant NNI departments, and external stakeholders… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …will collaborate globally with Formulation and Analytical Scientists, Clinical Operations, Regulatory Affairs CMC, and Clinical Development to collate the ... necessary information to author the Dose Preparation Instructions and address questions from the clinical sites. The candidate will optimize and continuously improve the Pharmacy Manual (PM) template with inputs from internal and external stakeholders.… more
- Omnicom Health (New York, NY)
- …we move medicine closer to patients. Together, we accelerate the impact of science. Associate Scientific Director ( Regulatory ) We are seeking a seasoned ... unique model of four powerhouses- Commercial & Marketing, Medical Affairs , Publications, Regulatory - that enables hyperconnected,...Associate Scientific Director with a proven track record of leading scientific… more
- Sun Pharmaceutical Industries (Princeton, NJ)
- …focus on dermatology, ophthalmology and onco-dermatology. Job Summary: We are seeking an Associate Director , HEOR to join our team. This role requires ... across product lifecycles, collaborating with cross-functional teams (clinical, medical affairs , regulatory ) to support enterprise needs. Methodological… more
- Kailera Therapeutics, Inc. (Waltham, MA)
- …cultures, perspectives, and experiences to join our team. What You'll Do: The Associate Director , Clinical Data Management plays a key role within the ... As the primary data management representative on the study management team, the Associate Director coordinates ongoing DM activities, partnering closely with key… more
- Ionis (Carlsbad, CA)
- …and contribute to our unique culture while you develop and expand your career! Associate Director / Director , Compliance Counsel SUMMARY: Reporting to the ... Director of Compliance, the Associate Director / Director /Compliance Counsel will have...will also have significant interaction with Commercial functions, Medical Affairs , Regulatory Affairs , Clinical Development,… more
- Temple School Of Medicine (Philadelphia, PA)
- …development among departmental staff. *Work with the Department Vice Chair of Academic Affairs , Department Chair, and Senior Associate Dean, Office of Faculty ... dynamic physician leader to serve as the Section Chief of Nephrology/Medical Director Kidney Transplant Program within the Department of Medicine. This leadership… more
- Clifford Chance (New York, NY)
- …as oversight of BD support for Derivatives, Structured Products and Financial Regulatory practices globally. The role-holder will also be the primary point person ... growth strategy for our Capital Markets, Structured Products, Derivatives and Financial Regulatory product offering. You will work with relevant partners, the wider… more
- Leerink Partners (New York, NY)
- …of the biotechnology and pharmaceutical industries including clinical development, regulatory affairs , business development, and commercialization Excellent ... Job Title: Equity Research Associate - Biopharma Reports to: Sr. Equity Research...This individual will work directly with a Senior Managing Director to assist in preparing and executing analyses of… more
