- Eisai, Inc (Nutley, NJ)
- …Agility, Industry/ Regulatory Knowledge, Mentoring/ People Development, Project Management , Statistical Programming Skills, Vendor ManagementEisai Salary ... within related therapeutic areas. Programming experience from inception through submission in related areas.Senior Manager, Statistical Programming sought by Eisai… more
- SMBC (New York, NY)
- …discipline to follow up on issues until resolved. + Must be well organized with project management skills. + Regulatory compliance experience at a broker ... and responses to regulatory inquiries and managing regulatory exams. + Support the preparation and submission...attributes. + Must be well organized with prioritization and project management skills on a global scale.… more
- Organon & Co. (Jersey City, NJ)
- …the product lifecycle.? + Lead development and execution of global product and project regulatory strategy(ies) by ensuring robust assessment of CMC changes, ... Identify, communicate and escalate potential regulatory issues to Organon Regulatory CMC management , as needed **Required Education, Experience and Skills**… more
- embecta (Parsippany, NJ)
- …in a fast-paced environment. + Strong communication, negotiation, influence and project management skills. + Demonstrated cross-functional collaboration and ... management activities which include identification and interpretation of regulatory requirements, review and preparation of regulatory submissions required… more
- Organon & Co. (Jersey City, NJ)
- …science, clinical operations, regulatory affairs, chemistry, manufacturing and control (CMC), project management and other partner groups as part of a ... submission modules, responses to agency questions and other regulatory documents as applicable. **Responsibilities** + Ensure early development plans incorporate… more
- Arup (New York, NY)
- …and 2-D hydrologic and hydraulic models for flood risk assessments, stormwater management , and sanitary and potable water systems. Software may include programs such ... of planning, design and construction + Successfully navigate the regulatory environment to gain approvals at various stages of... environment to gain approvals at various stages of project delivery + Proactively interact with our clients to… more
- System One (Tarrytown, NY)
- Regulatory Submission Project Management Specialist Location: Remote Term: 12-month renewable (CONTRACT TO HIRE) Target Pay: $30-$36/HR Must have recent ... PHARMA regulatory experience, preferably working on submissions. The Temp Regulatory Submission Project Management will provide support to the … more
- BD (Becton, Dickinson and Company) (Franklin Lakes, NJ)
- … regulatory guidance throughout the product development cycle prior to regulatory submission . + Identify and communicate appropriately quantified risks and ... and FDA guidance documents. + Strong critical thinking, communication, and project management skills. + Demonstrated global perspective, customer focus,… more
- Molina Healthcare (Yonkers, NY)
- **Job Description** **Job Summary** Establish a specifically designed Operational Regulatory Oversight program that effectively prevents and/or detects violation of ... regulations pertaining to the Health Care environment **Job Duties** The Operational/ Regulatory Oversight Sr. Analyst works with health plans and operations… more
- SMBC (New York, NY)
- …examination management , project management , and relationship management skills supporting examinations and regulatory projects. + Attention to detail ... the primary Regulatory Relations liaison for high priority engagements including management of complex regulatory examinations and inquiries. + Advise and… more
- Mount Sinai Health System (New York, NY)
- …and NYS regulations preferred. Prior leadership roles important, as is experience managing project groups. Non-Bargaining Unit, 620 - HSO Regulatory Compliance - ... provided. + Assists with the operational aspects of survey management , before, during and after the survey. This includes...with the respective accountable parties, ensures timely and complete submission of all regulatory reports to external… more
- Actalent (Parsippany Troy Hills, NJ)
- …to team processes and CMC- regulatory related processes. Essential Skills + Regulatory submission experience with FDA and CMC. + Strong technical writing ... Job Title: CMC Regulatory Affairs Scientist Job Description As a CMC...growing the product portfolio and ensuring effective life cycle management . Responsibilities + Lead or oversee the development of… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- …Resource Management + Change, Communications and Engagement + Performance Management + Regulatory Inspection and Standards Excellence (RISE) Management ... life cycle, including roles, systems, and processes. + Familiarity with global regulatory frameworks and submission processes (eg, NDAs, MAAs). + Proficiency… more
- Mount Sinai Health System (New York, NY)
- …least 2 years managing investigator-initiated trials preferred. + Proven track record in regulatory compliance, project management , and team leadership. + ... healthcare industry experience required, preferably in the areas of project management , change management , health...(eg, FDA, IRB, ICH). + Oversee the preparation and submission of regulatory documents, including protocols, amendments,… more
- Glenmark Pharmaceuticals Inc., USA (Elmwood Park, NJ)
- …which includes Commercial Division Heads, R&D, QA, Legal, Business Development, Project Management , Demand Planning, Marketing and others identified on ... Associate Director, Regulatory Affairs Department: Regulatory Affairs Location:...responsible to communicate these updates to the identified Sr. Management on a timely basis including R&D for unapproved… more
- Veolia North America (Haworth, NJ)
- …and time management skills. + Proficiency in Microsoft Office Suite; experience with project management or permit tracking software is a plus. + Ability to ... & Regulatory Coordination + Coordinate and manage the preparation, submission , and tracking of permit applications required for capital construction projects… more
- City of New York (New York, NY)
- …Manager for Conversions and Completions will have responsibility for all aspects of project management related to monitoring the construction and conversion of a ... investment, coupled with a commitment to reduce administrative and regulatory barriers, is a multi-pronged strategy to tackle New...but not limited to the following: - Responsible for project management related to monitoring the construction… more
- City of New York (New York, NY)
- …Avenue, LIC, NY 11101 Only candidates who are permanent in the Construction Project Manager title or those who are reachable on the Open-Competitive List (Exam ... Design & Construction, Safety & Site Division, seeks a Project Manager. Under the general direction of the Chief,...Safety Plan (WPSP) applications from abatement contractors prior to submission to the New York City Department of Environmental… more
- System One (Newark, NJ)
- …Suite knowledge and the ability to work independently using the software. Project Management experience is required. RESPONSIBILITIES: + Coordinate with ... Project Scope document with all supporting documentation for submission . + Create project timeline include Initial...of a degree + Minimum 5 years of proven project management experience, including the design of… more
- Bayer (Whippany, NJ)
- …and life cycle management ; + Plan and deploy skilled resources against project priorities; + Contribute to development of budget and work within those allocated ... to make a real difference, there's only one choice.** **Senior Benefit Risk Management Lead, Oncology** The Senior Benefit Risk Management (BRM) Lead /Oncology… more
