- 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)
- … regulatory strategy, issues, and risks in written and verbal format to regulatory senior leadership team and other governing bodies required Travel: Ability ... centered around rare diseases and immune disorders. Summary: Responsibility for regulatory strategy to support the development of biomarkers, companion diagnostic… 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
- 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
- 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 ... of relevant medical communications deliverables aligned with the Medical Affairs strategic plan for assigned therapeutic area(s). These deliverables include… more
- Genmab (NJ)
- … regulatory policy and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr. Director, Labeling, ... 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… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …affairs , market access and policy/advocacy (MAPA), Centers of Excellence (COEs), regulatory affairs , other relevant NNI departments, and external stakeholders ... 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 in… more
- Merck & Co. (North Wales, PA)
- …with other leaders in Clinical Development and Global Regulatory Affairs .--The AVP provides leadership and direction through senior -level and first-line ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… 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 -...project-based tasks and/or special projects as assigned by the Senior Director, Regulatory Affairs . Additional… more
- The City University of New York (Hunter, NY)
- …School of Nursing (HBSON) invites innovative and visionary nurse leaders to apply for Senior Associate Dean for Academic Affairs . The HBSON is seeking ... to the Dean and is a key member of the School Executive Leadership Team. The Senior Associate Dean for Academic Affairs will provide leadership in developing… more
- Omnicom Health (New York, NY)
- …a unique model of four powerhouses- Commercial & Marketing, Medical Affairs , Publications, Regulatory - that enables hyperconnected, audience-centric engagement ... to patients. Together, we accelerate the impact of science. Associate Scientific Director ( Regulatory ) We are seeking...SVP of Scientific Communications and will work collaboratively with senior leaders within the company and the group. We… more
- Abbott (Alameda, CA)
- …to be flexible when priorities change. Working knowledge of GCP, Clinical and Regulatory Affairs . Proficient with Microsoft Suite. Travel Requirements Must be ... Practices (GCPs), ICH guidelines, Federal Regulations, department procedures and applicable regulatory requirements. Responsible for assisting senior staff in… 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...research team. This individual will work directly with a Senior Managing Director to assist in preparing and executing… more
- Nuvalent, Inc. (Cambridge, MA)
- …oncology drug development, and company building. The Role: Reporting to the Senior Medical Director, Pharmacovigilance, the Associate Director, Drug Safety and ... review of new or existing safety documents to ensure compliance with relevant regulatory requirements, such as protocols, safety summaries and regulatory reports… more
- HealthCare Resolution Services (Portsmouth, VA)
- …required documents and records for the active duty, AFRC and ANG to the Veteran Affairs Medical Service Coordinator, the local MEB, the IPEB, the FPEB and other IDES ... stakeholders in accordance with regulatory guidance. Ensures LOD processing is accomplished for each...pay purposes and unable to manage his/her own legal affairs , the PEBLO provides guidance and assists the legal… 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 ... efficient allocation and compliance with institutional financial goals. *Provide senior clinical leadership for the Nephrology/Kidney Transplant Section, fostering a… more
- UnitedHealth Group (Hartford, CT)
- …Connecting. Growing together. This position is in UHC Legal, Compliance and Regulatory Affairs (LCRA) -Operations and Experience Legal team. This position ... Primary Responsibilities: Advise on the implementation of federal and/or state legal/ regulatory requirements impacting the health care industry (particularly in the… more
- Hackensack Meridian Health (Paramus, NJ)
- …Minimum of 2 years experience in a Senior Clinical Data Coordinator or Senior Regulatory Specialist role, or at least 4 years related experience in the ... compliant study conduct according to all relevant local, federal, and state regulatory and institutional Polices and Standard Operating Procedures. This role carries… more
- Brookdale Senior Living, Inc. (Whittier, CA)
- …and Full Time Benefits Eligibility Medical, Dental, Vision insurance 401(k) Associate assistance program Employee discounts Referral program Early access to earned ... sales and profitability and for developing the local team to become the preferred senior living community in the market. The expectations for this position is that… more
- 3M (Austin, TX)
- **Job Description:** ** Senior Regulatory Affairs Associate ** **Collaborate with Innovative 3Mers Around the World** Choosing where to start and grow your ... environments to a 3M career.** **The Impact You'll Make in this Role** As a ** Senior Regulatory Affairs Associate ** , you will have the opportunity to… more
