- Merck & Co. (North Wales, PA)
- …corporate standards and policies and business objectives.Actively participate in labeling and global regulatory team meetings to ensure support for anticipated ... Job DescriptionReports to the Director/ Senior Director in the Office of Promotion and...in the Office of Promotion and Advertising Review (OPAR)The Associate Director is responsible for the review and approval… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 ... contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC...team and serves as ad hoc member to the Global Project Team for late stage projects. This position… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 ... research areas centered around rare diseases and immune disorders.Summary The Associate Director, RACMC Portfolio Products, will be responsible for regulatory… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Vice President (AVP) has primary responsibility for the planning and directing clinical research activities involving new or marketed ... drugs for oncology indications. The Associate Vice President will manage and oversee the entire cycle of clinical development, including study design, initiation,… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe Associate Vice President (AVP)/Section Head, Global Clinical Development, Ophthalmology will focus on driving strategy, development, and ... excellence in the late development of ophthalmology assets.May serve as a senior therapeutic area content expert within the company, providing input into research… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …Responsibilities Represent MSAT at joint technical and CMC committeesPartner closely with senior leadership to achieve global alignment on all technical Carvykti ... and external CMO sitesDrive new process version plans and content for regulatory submissionsEnsure global records are consistent and maintained to achieve… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …equal opportunity employer including veterans and people with disabilities.SummaryThe Associate Director will be responsible for developing and implementing Clinical ... hands on population PK and PKPD analyses and participate in regulatory interactions and submissions representing the Clinical Pharmacology and Pharmacometrics/… more
- Merck & Co. (Rahway, NJ)
- …to pursue and subsequent study design, initiation, execution, monitoring, analysis, regulatory filing, and publication. Specifically, The Senior Clinical ... Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary...closely with a cross-functional group of experts in commercialization, regulatory affairs, statistics, and manufacturing to manage clinical development… more
- Merck & Co. (Durham, NC)
- Job DescriptionPosition Description: Senior Instrumentation Technician (O3) The Senior Maintenance Technician is responsible for providing equipment ... systems)Required Experience and Skills: Required Experience and Familiarity of regulatory requirements in accordance with GMP manufacturing operations Preferred… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …pharmaceutical/oncology project development preferred- 1 or More Years Extensive knowledge of global CMC regulatory requirement and preferably NDA or BLA/MAA ... 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
- Merck & Co. (North Wales, PA)
- …is based out of Upper Gwynedd, PA, reporting directly to the Associate Director, US Vaccine Portfolio Marketing Strategy & Implementation Lead.- Responsibilities ... Review Team (PRT) approvals, and production.Maintains working knowledge of regulatory guidance & delivers compliant programs.Manages creation and monitoring of… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …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 ... complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: Device Development Associate Principal Scientist - Development Strategy, Design Controls and Risk Management Our company's ... from early design concept definition through commercialization to support regulatory filing, product launch, and post-market surveillance.This position will interact… more
- Tris Pharma (Monmouth Junction, NJ)
- …have an immediate opening in our Monmouth Junction, NJ facility for an Associate Director, Alliance Management.Tris Pharma has a long track record of successful ... alliances, from global commercial partnerships to R&D collaborations to manufacturing/distribution partnerships....departments across all stages of the product lifecycle. The Associate Director, Alliance Management will be accountable for managing… more
- Merck & Co. (Rahway, NJ)
- …Biologics and Biopharmaceutics, have 8-10 direct reports composed of experienced, senior and associate biopharmaceutic scientists.- The successful candidate will ... Job DescriptionOur company is a global health care leader with a diversified portfolio...technical & domain expertise, effective communication skills, understanding of regulatory environment, and vision to influence the regulatory… 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 ... Job DescriptionOur Company is a global health care leader with a diversified portfolio...manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile… more
- Merck & Co. (Rahway, NJ)
- …Based Sciences and will be directly responsible for a team of approximately 10-15 senior and associate level scientists in Rahway, New Jersey. -The position is ... bring analytical representation and expertise to project teams and support regulatory filings (eg, INDs/IMPDs and BLAs).-The Director selects, trains, and… more
- Fidelity TalentSource LLC (Boston, MA)
- …international sites (India & Ireland) and advisory reviews over strategic initiatives. The Senior Associate role will deliver significant value to the business ... Job Description:The Global Financial Controls Center of Excellence (GFC-CoE) is...processes, and systems. This role will report to a Senior Manager or a Director within the GFC function.… more
- Fidelity TalentSource LLC (Westlake, TX)
- …and Planning, Employee Compliance, Workplace Solutions Compliance, Advice Solutions Compliance, Regulatory Compliance, Global Sanctions and Risk Assessment and ... Job Description:The Role The Senior Manager, Business Analyst is part of a...Skills You BringBachelor s degree requiredPrevious project management, audit, regulatory , risk or compliance environment experience required8+ years of… more
- Fidelity TalentSource LLC (Westlake, TX)
- …Reference team within Fidelity Fund and Investment Operations (FFIO) is a global investment data management organization that specializes in the sourcing and ... accounting, compliance, performance and analytical data in support of global investment decision making organizations.\u00A0 Security Reference, a division of… more
