- Formation Bio (New York, NY)
- …commercial-stage biologic products, ensuring alignment with company goals and global regulatory standards . Team Development Build and lead a high-performing CMC ... efficiently.About the PositionWe are seeking a Senior Director, Biologics to lead all Chemistry, Manufacturing, and Controls (CMC) activities related to biologic… more
- Eisai, Inc (Nutley, NJ)
- …studies are conducted efficiently, within budget, and in compliance with regulatory standards . The Head of Clinical Operations leads teams of study managers and ... clinical operations function, ensuring compliance with GCP and regulatory standards .Develop and implement strategic vision and hands-on operational management… more
- Eisai, Inc (Nutley, NJ)
- …close-out) under the direction and supervision by study Clinical Operations Lead (s). Plans, support, creates, and communicates clinical study timelines. Gathers ... invoices and support the vendor reconciliation processAdhere to financial standards , guidelines and compliance requirements Technical Competencies: Functional development… more
- Eisai, Inc (Nutley, NJ)
- …Eisai's Neurology business group; contributes to the development of departmental standards and guidelines. 10%4. Works with the internal/CRO statisticians and ... of CRO deliverables and on QA of data outputs. 10%5. Functions as lead statistician in global registration trials and manages all related statistical activities.… more
- Daiichi Sankyo, Inc. (New York, NY)
- …to the creation and supply of innovative pharmaceutical therapies to improve standards of care and address diversified, unmet medical needs of people globally ... NY. Nature and Scope: Demonstrate Daiichi-Sankyo values, mission, and standards , and represent the company in a positive and...to assigned customers, using approved messages and resources. Build, lead , and manage a diverse team of high performing… more
- Formation Bio (New York, NY)
- …and external reviewers (adjudication meetings). Leads the development of style standards and guidelines for preparation of documents, including those submitted to ... and regulatory documents to support drug development programs. Experience as lead writer for key clinical and regulatory documents required. Experience mentoring… more
- Merck & Co. (Rahway, NJ)
- Job Description Lead the Future of Biologics Drug Substance Commercialization! Are you a bold, strategic thinker with a passion for biologics? We're looking for a ... Biologics Science & Technology (S&T) portfolio. In this high-impact role, you'll lead the Drug Substance Working Group (DSWG), mentor scientific talent, and partner… more
- Merck & Co. (Rahway, NJ)
- …Reporting directly to the Biologics Drug Substance Commercialization Leader, you will lead the Cell Banking working groups and drive innovation in biologics DS ... Impact:Collaborate with colleagues across the US and internationally to elevate standards in cell banking manufacturing, testing, and storage. Your work will… more
- Merck & Co. (Rahway, NJ)
- …to support a compliant workplace.Develop and manage company's Industrial Hygiene standards and technical guidelines to ensure compliance and reduction in workplace ... Industrial Hygiene risks. Lead global continuous improvement initiatives to improve global Industrial...operations.Being a change agent to ensure all changes to standards , guidelines, systems and tools achieve the desired outcome.Partner… more
- Merck & Co. (Rahway, NJ)
- …Manager to join the RaDS Product organization. The position will report to the- Lead of the Disease Biology and PharmTox Product Line. The ideal candidate will ... leading squads and maintaining product lifecycle Manage scientific applications and lead squads to build user-friendly scientific data and technology products.… more
- Merck & Co. (Rahway, NJ)
- …HTA/reimbursement agencies and health systems globally. The ability to participate and lead cross-functional teams is a critical part of this role. This position ... with company Policies and SOPs and world-wide regulations and standards , including Good Pharmacoepidemiology Practice (GPP) for applicable work.-Develops American… more
- Merck & Co. (Rahway, NJ)
- …Quality & Regulatory QMS group, the Associate Director will participate in and/or lead various initiatives in support of our QMS Purchasing Controls and Device ... Management Systems, etc.Support MDCP sites with new/revised QMS Quality Standards and/or Global Procedures.Perform related duties, as assigned. Skills Preferred… more
- Merck & Co. (Rahway, NJ)
- …and Diagnostics, in this role, you will serve as the translational lead on late-stage immunology programs, driving the Precision Medicine objectives in alignment ... Awareness, Cross-Functional Teamwork, Dermatology, Drug Development, Ethical Compliance, Ethical Standards , Immunoassays, Immunotherapy, Management Process, Medical Research, Mentorship, Parasitology,… more
- Merck & Co. (Rahway, NJ)
- …regulations.Experience ensuring compliance of a clinical laboratory with regulatory standards .Experience with the development and analytic validation of digital ... record of scientific contributions to the scientific community.Demonstrated ability to lead and manage projects in a fast-paced environment.Ability to interact well… more
- Merck & Co. (Rahway, NJ)
- …control environment at our company.On occasion, the incumbent will be expected to lead small teams of auditors audits with limited management supervision in addition ... (including walkthroughs and sample testing) in line with the established quality standards and timelines.Collaborate with the audit team in the writing of audit… more
- Merck & Co. (Rahway, NJ)
- …Biologics programs (approximately 10-15 programs), and leading multiple Director lead Development teams, overall approximately 40-50 scientists. Strategic partnering ... knowledge of and hands-on work in applying regulatory guidance and quality standards related to product release and safety.Current Employees apply HERE Current… more
- City of New York (New York, NY)
- …BIM/CADD technology to streamline engineering design processes. BEDC is seeking to hire a Standards Lead to manage the standards program, and records ... Reporting directly to the Deputy Director of Engineering Services, the Standards Lead will ensure consistency in design deliverables across all capital programs… more
- City of New York (New York, NY)
- …BIM/CADD technology to streamline engineering design processes. BEDC is seeking to hire a Standards Lead to manage the standards program, and records ... Reporting directly to the Deputy Director of Engineering Services, the Standards Lead will ensure consistency in design deliverables across all capital programs… more
- City of New York (New York, NY)
- …BIM/CADD technology to streamline engineering design processes. BEDC is seeking to hire a Standards Lead to manage the standards program, and records ... Reporting directly to the Deputy Director of Engineering Services, the Standards Lead will ensure consistency in design deliverables across all capital programs… more
- TYLin (New York, NY)
- …and load rating evaluations, ensuring full compliance with AREMA, AASHTO, and agency-specific standards . + Lead and manage major rail bridge projects from ... + Transit team. In this high-impact role, you will lead the design and delivery of complex railway bridge...expertise in rail structures, a thorough understanding of industry standards , and a proven track record of leading multidisciplinary… more
