- Daiichi Sankyo, Inc. (Bernards, NJ)
- …working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and ... 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
- Eisai, Inc (Nutley, NJ)
- …(Legal/ Compliance)Eisai Salary Transparency Language:The base salary range for the Associate Senior Counsel, Market Access is from :189,100-248,200Under current ... price reporting, patient support, as well as other pharmaceutical regulatory counseling. Essential Functions: Provides proactive and day-to-day legal support,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionDevice Development Associate Principal Scientist - Development Strategy, Design Controls( Associate Director Equivalent) Our company's Device ... from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.This position will interact… 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. (Rahway, NJ)
- Job DescriptionRole SummaryUnder the guidance of a senior leader, an Associate Principal Scientist/ Associate Director, has primary responsibility for ... reimbursement and market access, and provide input into clinical, regulatory , payer/access, marketing and evidence generation strategy and programsIn collaboration… more
- Merck & Co. (Rahway, NJ)
- …as a lead GCS Planning program representative ) such as clinical development, regulatory , quality and other supply chain areas to negotiate timelines ,- strategies ... communicate with stakeholders at various levels, including cross-functional teams, senior management, external vendors, and clinical sites. Strong negotiation,… 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 in ... consistency with brand/therapy area vision and message. Relationships Reports to Senior Director of Cardio Renal Marketing Responsible for providing interface with… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Pediatrics will focus on driving strategy, development, and life-cycle ... the pediatric section of the Vaccine Clinical Development TA.May serve as a senior therapeutic area content expert within the company, providing input into research… 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 ... hoc internal communications activities including department newsletter, and other senior -level medical communication initiatives as needed.Manage and support the… 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
- 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, ... between CRO / vendors / AROAdditional non-study related activities: Occasional senior management interactions at FIHC, WDC; Initiates contact w/KOL and prepares… more
- Merck & Co. (Rahway, NJ)
- …of Biologics and Biopharmaceutics, have 10-15 direct reports composed of experienced, senior and associate scientists.- The successful candidate will effectively ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Merck & Co. (North Wales, PA)
- …Global Regulatory Affairs.--The AVP provides leadership and direction through senior -level and first-line managers and statistical staff focused on end to end ... art scientific methodologies and tools to enable the discovery, development, regulatory approval, manufacturing, and marketing of medical drugs and vaccines for… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …to execute daily production schedules.Will have 3-6 direct reports ranging from Associate Director, Senior Manager, and Manager.Oversee the hiring, development, ... controls, and maintain permanent inspection readiness and actively support regulatory inspections.Lead facility operating review meetings and sponsor various… more
- Aequor (Thousand Oaks, CA)
- …Urgent role. Shortlisting will begin EOD Weds 7/23 Standard business hours Supply Chain Senior Manager - Global Supply Chain Leader What you will do Let's do this. ... patient supply. With the end-to-end supply chain oversight of products, the Senior Manager will be responsible for establishing supply chain resolutions to mitigate… more
- Eisai, Inc (Phoenix, AZ)
- …If this is your profile, we want to hear from you. The Senior Oncology Sales Specialist is responsible for meeting/exceeding sales goals through promoting Oncology ... products within an assigned territory in a compliant and appropriate manner. The Senior Oncology Sales Specialist represents and promotes assigned brand(s) in the IV… more
- Above Lending (Chicago, IL)
- …well-being. We are committed to making credit more affordable and accessible. The Senior Credit Associate position will analyze data to develop new strategies ... we encourage you to apply for the position of Senior Credit Associate at Above Lending. Join...credit scorecards and machine learning models. Ensure compliance with regulatory standards (eg, ECOA, FCRA, UDAAP) in all analytical… more
- Clinical Dynamix, Inc. (Waltham, MA)
- …place asap)! Reporting to the Sr. Director, Clinical Excellence Operations the Senior Manager/ Associate Director, Records Management will be responsible for ... activities across all therapeutic areas of development at Company. The Associate Director of Records Management will provide direct management and leadership… more
- Ensemble Health Partners, Inc. (Romney, WV)
- …these functions while meeting the mission of Ensemble Health Partners and all regulatory compliance requirements. The Senior Patient Access Specialist will work ... to work on-site at Valley - Hampshire Hospital in Romney, WV The Senior Patient Access Specialist is responsible for performing admitting duties for all patients… more
