- Daiichi Sankyo, Inc. (Bernards, NJ)
- …partner side) CDx RA Policy and Intelligence : Keep abreast of the changing global regulatory environment for devices and share/educate CDx department on these ... procedures.Understanding of strategic and tactical role and deliverables of Global Regulatory Strategy in the Drug and Device Development and Commercialization… more
- Merck & Co. (Rahway, NJ)
- …Required experience and skills: Min. 5-10 years of experience with Pharmaceutical Regulatory Affairs Operations with Labeling Process and/or Digital Enablement ... Training Programs, FDA Regulations, Management Process, Pharmacovigilance, Policy Implementation, Regulatory Affairs Compliance, Regulatory Compliance, … more
- Merck & Co. (Upper Gwynedd, PA)
- …and project regulatory strategy(ies) by ensuring robust assessment of global regulatory CMC requirements and critical evaluation of supporting documentation ... Job DescriptionGRACS CMC - Associate Principal Scientist, CMC, R4 - Pharm Pre-approval...to GRACS CMC management, as neededDemonstrate an understanding of regulatory affairs and apply this understanding to… 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
- 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 ... medicines to help people. Under the Group's 2025 Vision to become a " Global Pharma Innovator with Competitive Advantage in Oncology," Daiichi Sankyo is primarily… more
- Eisai, Inc (Nutley, NJ)
- …strategic imperatives for assigned therapeutic area(s). Collaborate with other stakeholders across Global & US Medical Affairs functions and regions, in addition ... 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… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionRole SummaryUnder the guidance of a senior leader, an Associate Principal Scientist/ Associate Director, has primary responsibility for ... development of American Managed Care Pharmacy (AMCP) dossiers for US payers, and Global Value Dossiers for use by local subsidiaries in their HTA submissions. The… more
- Genmab (NJ)
- …various regulatory policy and/or intelligence deliverables. This role will be within Global Regulatory Affairs (GRA) and will report to the Sr. ... love to have you join us!The Global Regulatory Labeling, Policy and Intelligence Associate Director will primarily be responsible for leading the development… more
- Insmed Incorporated (San Diego, CA)
- …also key duties. Collaboration with R&D, Process Development, Quality Control, and Regulatory Affairs is essential, as is facilitating technology transfers and ... Company DescriptionInsmed is a global biopharmaceutical company on a mission to transform...PDT as required by the business.ResponsibilitiesThe Analytical Development Operations associate director is responsible for building a team to… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …you in? Are you ready to experiment with us? The Position The Associate Director Consumer Marketing will be responsible for supporting the development and execution ... and finance teams to ensure alignment with business objectives and regulatory requirements. Essential Functions Brand/Therapy Area Management Develop and execute… more
- Merck & Co. (North Wales, PA)
- …BARDS and will work collaboratively with other leaders in Clinical Development and Global Regulatory Affairs .--The AVP provides leadership and direction ... marketing of medical drugs and vaccines for the benefit of patients and global human health.The Associate Vice President (AVP), Late Development Statistics,… more
- Abbott (San Diego, CA)
- …for diversity, working mothers, female executives, and scientists. The Opportunity This position, Associate Director Regulatory Affairs , works out of our ... New Product Introduction (NPI) team, reporting to the Director of Global NPI and US Regulatory Affairs . We're empowering smarter medical and economic… more
- DermBiont (Emeryville, CA)
- …employees to do their best work. Overview: We are seeking a highly motivated Regulatory Affairs and Quality Assurance (RA/ QA) experienced professional to join ... and execution of regulatory submissions for assigned programs to global regulatory authorities (FDA, EMA, etc.). Support and assist with Pre-IND meetings,… more
- System One Holdings, LLC (Tarrytown, NY)
- …report teams. Collaboration with Signal Management , Medical Safety , Clinical , Regulatory Affairs , and Biostatistics groups. Experience in matrix team ... Job Title : Temp - Associate Director, Aggregate Reporting, GPS Type : Contract...Safety (GPS) and with functional areas (Epidemiology, Clinical Development, Regulatory Affairs , Statistics, etc.) contributing to aggregate… more
- Nurix (San Francisco, CA)
- …These responsibilities involve working closely with Clinical Operations, Clinical Development, Medical Affairs , Regulatory Affairs , Clinical Trial Sites and ... and maintaining GCP SOPs and providing associated training Understanding and interpreting global regulatory agency policies, guidelines and ensuring that Nurix… more
- Texas Instruments (Washington, DC)
- …policymakers, regulatory agencies, and stakeholders. The evolving trade and regulatory environment within TI's global manufacturing and business footprint ... partners, and internal and external stakeholders to advance a policy and regulatory environment that supports TI's business priorities. Texas Instruments is seeking… more
- Abbott (Alameda, CA)
- …inspections. Required Qualifications Bachelor's or Master's degree in Engineering, Life Sciences, Regulatory Affairs or a related field or equivalent combination ... Abbott is a global healthcare leader that helps people live more...serve people in more than 160 countries. JOB DESCRIPTION: Associate Director, Complaint Handling Working at Abbott At Abbott,… more
- BioSpace (Irvine, CA)
- …assigned projects. Specific areas of work may include clinical trials, patient safety, and global medical affairs (GMA). The Associate Director works in ... Instagram , YouTube , LinkedIn and Tik Tok . Job Description The Associate Director, Statistics - Eye Care provides statistical leadership for clinical development… more
- Eli Lilly and Company (Indianapolis, IN)
- …that elevate business impact. This position will report to the Associate Vice President, Corporate Affairs , Lilly Immunology. Responsibilities include: ... and international communication peers, advocacy, commercial, marketing, medical, publications, regulatory , legal, global affiliates, etc.) to define and… more
