- Merck & Co. (Rahway, NJ)
- Job DescriptionAssociate Director , Business System Labeling Management Required experience and skills: Min. 5-10 years of experience with Pharmaceutical ... Regulatory Affairs Operations with Labeling Process and/or Digital Enablement...soon as possible.Job Description: Seeking a full-time Business System Associate for the Labeling Operations area within the GRACS… more
- Merck & Co. (Upper Gwynedd, PA)
- …with risk mitigation measures.-Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of global ... Job DescriptionGRACS CMC - Associate Principal Scientist, CMC, R4 - Pharm Pre-approval...CMC, R4 - Pharm Pre-approval Reporting to the Sr Director / Director /Principal Scientist/Sr Principal Scientist in Pre-approval Pharmaceutical… more
- Merck & Co. (Rahway, NJ)
- …Areas, Portfolio Management, Process Optimization, Project Management, Project Portfolio Management (PPM), Publications Management, Regulatory Compliance, ... operational/executional arms within the business.-- - - The Program Clinical Supplies Project Manager (Program CSPM) serves as the primary program-level GCS point of… 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
- 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 ... and serves as ad hoc member to the Global Project Team for late stage projects. This position manages...& variations (eg, NDA, BLA, MAA). This position authors regulatory documents where necessary with supervision. This position conducts… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a Technical Lead, you will report into Director , Chemical Technical Operations, External Manufacturing API Technology, and play a pivotal role in ... matters.Review process change requests and deviation reports while ensuring regulatory compliance.Education and Minimum Requirements:Bachelor's degree in engineering, chemistry… more
- Merck & Co. (North Wales, PA)
- …team. You will build and coach your team in the development of project management, communication, and collaboration skills in support of our clinical trials.Job ... engagements. This includes the ability to:--Strong knowledge of clinical research regulatory requirements (eg, GCP and ICH) Proven ability to manage competing… 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)
- …areasExperience with regulatory submissions including writing / review of regulatory filings including INDs and NDAs.Exposure to project / engineering ... of the Capital Process having participated on a large capital project teamExperience in regulatory compliance expectations across all phases… more
- Eisai, Inc (Exton, PA)
- …technology transfer to external partners (as required). The Associate Director sets strategic directions and project priorities, providing scientific ... your profile, we want to hear from you. The Associate Director of Biologics Operations Upstream and...Control, Regulatory , and CMC Program Management departments.The Associate Director of Biologics Operations maintains knowledge… more
- Merck & Co. (Durham, NC)
- …Manufacturing Operations, Drug Delivery Systems and Devices within our Manufacturing Division ( Associate Director ).-This role serves as a Virtual Plant Manager - ... contact for all dealings between our Company and the External Partner, the Associate Director External Manufacturing Operations is accountable for establishing a… 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, ... of an immunotherapy in the treatment of multiple myeloma.Legend Biotech is seeking Director of Operations as part of the Technical Operations team based in Raritan,… 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, ... scientific direction to Clinical Operations. Represents Clinical Development on Project Teams.Responsibilities: Study Strategy: Provides the strategic direction to… more
- Merck & Co. (Rahway, NJ)
- …process validation, second generation process development and authoring of regulatory submissions.-Under the general scientific and administrative direction of the ... Director in Biologics Cell Culture Sciences group and working...next generation process development and characterization, process validation, and regulatory submission authoringIn this role, the successful candidate will… more
- Merck & Co. (Durham, NC)
- …blood test, chest x-ray Position Responsibilities:This role reports to an Operations Associate Director and supports the product transfer for a new ... Excellence, Process Optimization, Process Troubleshooting, Production Operations, Production Support, Project Management, Regulatory Compliance, Teamwork, Training and… more
- Revolution Medicines (Redwood City, CA)
- …with cancers harboring mutations in the RAS signaling pathway. The Opportunity: The Associate Director of Regulatory Affairs will independently represent ... and be able to provide clear and concise feedback to management and project teams, facilitate decision-making and provide effective leadership to ensure successful … more
- Cedent (Cambridge, MA)
- Summary: Reporting to the Chief Medical Officer and collaborating with external regulatory advisors, this role is responsible for developing and executing ... regulatory strategies from early development through late-stage clinical programs....is a plus. Experience in ophthalmology is an advantage. Project management experience is beneficial. Strong oral and written… more
- UBS (New York, NY)
- …change capabilities across a range of business functions? We're looking for a Associate Director , Business Manager to: *Monitor, analyze and present financial ... new business initiatives. *Identify, evaluate, and mitigate risks, adhering to regulatory and operational risk standards through completing deep-dives and ad-hoc… more
- AbbVie (Florham Park, NJ)
- …on X, Facebook, Instagram, YouTube, LinkedIn and Tik Tok. Job Description The Associate Director , Statistics - Eye Care provides statistical leadership for ... may include clinical trials, patient safety, and global medical affairs (GMA). The Associate Director works in partnership with experts in multiple disciplines… more
- Genmab A/S (Princeton, NJ)
- …a fit? Then we would love to have you join us! Genmab is looking for an Associate Director , Global Regulatory Affairs, Regulatory Strategy to be a part ... but is not limited to: Act as the US/Global Regulatory Leader (GRL) for assigned project (s) and...the US/Global Regulatory Leader (GRL) for assigned project (s) and be responsible for the development, implementation and… more
