- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Manager , Regulatory Affairs - Regulatory Project Management (RPM) provides planning ... and coordination supports for global and US regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US … more
- Aequor (Thousand Oaks, CA)
- …for product manufacturing and quality programs throughout product lifecycle. Title: Regulatory Project Coordinator (RPC)Job Description: o Assist Regional ... mixed background not just lab but manufacturing and process development. This manager position within CMC will facilitate product development and global registration… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …well as other research areas centered around rare diseases and immune disorders. Summary The Regulatory Data Manager will be a key member of the Global ... business requirements for reporting and analyticsEngage with key stakeholders, including Regulatory Affairs teams and cross-functional project team members, to… more
- Aequor (Seattle, WA)
- Job Description: Position: Technical Project Manager Location: Seattle WA Top Skills: 5&plus years' experience in bio tech/life sciences project management; ... with end-to-end CMC drug development. Familiarity with alliance management Job Description The Technical Project Manager (PM) will be a key member of the Cell… more
- Merck & Co. (Rahway, NJ)
- …to the project . This is an unmatched opportunity to build your career as a project manager in a highly complex and important field. You will be given the ... does and our impact to the business. Direct experience as a project manager for a development pipeline asset.- Mentoring & networking opportunities within the… more
- Aequor (New Brunswick, NJ)
- Job Description: Supply Chain Project Manager100% onsite required for training and once done min 50% required onsite as per manager .Job Summary:The primary ... Coordinates activities and manages teams engaged in the planning, project management and execution of supply chain projects. Participates as… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …an immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking a Project Manager , Process Engineer- Consultant as part of the Global MSAT team ... only technology vendor partners, but with Manufacturing, Process Development, Quality, and Regulatory to ensure approval of the selected platform. The candidate will… more
- Aequor (Thousand Oaks, CA)
- …projects, programs or directing the allocation of resources. COMPETENCIES/SKILLS: Project management skills, Strong organizational skills, including ability to ... group. Ability to evaluate documentation/ operations according to company and regulatory guidelines Ability to interact with regulatory agencies. Demonstrate… more
- Sun Pharma (Taro Pharma) (Princeton, NJ)
- …Mentoring, Motivating, Training and Oversight for a team of Project Managers, Clinical Research Associates (CRAs), Clinical Trial Associates (CTAs).Oversee ... negotiation and Clinical Study Agreement finalization, Translations, EC and Regulatory submission, Site initiation etc.).Oversee, manage and assess vendor… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThe drug development Project Manager is part of Global Project and Alliance Management (GPAM) which sits in the Research & Division ... organization of our company.- Position Description/Summary: The GPAM Associate Director, Project Manager , is a core member of Early Drug Development and/or Late… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Non-GxP activities, assuring that these systems are compliant with global regulatory and Daiichi Sankyo requirements, and business expectations. Executes the Global ... of system validation or qualification needed to achieve and maintain regulatory compliance regardless of service methodology (SaaS, On-Prem, Service Provider… more
- Merck & Co. (Durham, NC)
- Job DescriptionThis role is within a capital project start-up in Durham, North Carolina. The new facility will include end-to-end processing of drug substances, drug ... the team finishes the design and construction of the facility, the Operations Manager will play a critical role in supporting the Global Engineering Services team,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …this position possesses a working knowledge of clinical operations and relevant regulatory requirements. This position has experience working on Phase I-IV studies ... Finally, this position has moderate skills in continuous improvement, project management, change management, and risk management. Responsibilities Leadership,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …ensure deliverable quality, and expedite the preparation of oncology compound regulatory submission. It will also to maintain institutional knowledge across oncology ... (ISS) for oncology submission compounds, and expedite the preparation of regulatory submissions. Responsibilities include: review Case Report Form (CRF) annotation… more
- Eisai, Inc (NJ)
- …is your profile, we want to hear from you. Job Summary The Senior Manager , Medical Writing will be the designated Lead Medical Writer for approximately 3-4 Programs. ... protocols, and protocol amendments often acting as the compound leadLead project management for medical writing deliverable by defining milestones, managing budget,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Manager , Clinical Quality Management (CQM), Inspection Readiness Lead (IRL) is responsible ... Clinical Team, the inspection preparation team, and transversal clinical improvement project working groups which are established to ensure continued inspection… more
- Merck & Co. (North Wales, PA)
- …skills as part of a global, cross-functional team. You will apply project management, communication, and collaboration skills in support of our clinical trials.- ... closeout activities).May be responsible for tracking study timelines using project management tools.Shares technical expertise with team members.May interact with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. Summary The Manager , Global Clinical Operations (GCO) Functional Excellence (FxExc), will help support ... functional excellence activities to include, but not limited to, the project management of workstreams and strategic imperatives, training and onboarding, metrics… more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you. Job Summary The Senior Manager , Alzheimer's Disease - Site of Care Marketing will assist with the development and ... business partners and external agenciesPotentially Lead or Co-lead cross-functional project teams involving Marketing, Sales, Managed Markets/Market Access, Legal, … more
- Merck & Co. (Durham, NC)
- …last several years; currently Durham employs 1,000+ people.This role as a Manager , Operations will be an energetic, leader with strong interpersonal, leadership, and ... product at a competitive cost consistent with our Company, Regulatory Agency, and State and Local code requirements for...as a supervisor/coach or indirectly as part of a project or through routine process execution).Ability to manage multiple… more
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