- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Study Team (IST) representative or IST leader on study team; Responsible before senior management for the creation and execution of development strategies for ... strategy; Leads Integrated Project Team (IPT) working closely with Global Project Management to ensure cross-functional coordination and focus to agreed… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …inquiries. Expert level written and verbal communication skills, strong decision-making abilities, clinical project management skills and attention to detail ... (FDA) regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines.The Senior Clinical Study Manager will have routine interaction… more
- Aequor (Thousand Oaks, CA)
- …as the top end of the experience level. Ideally candidates who have strong project management experience as well as product development experience (Have skills ... hands off leader, candidates who have familiarity with Pharma; Clinical Trials. Qualities an ideal candidate possess that will...the ability to present themselves well.* 6&plus years of project management experience - Pharma familiar with… more
- Merck & Co. (South San Francisco, CA)
- … project teams, and development functions.Partner with scientists and management to produce and edit nonclinical pharmacology reports and submission ... documents.Create documents that effectively and clearly describe research results, product candidates, and other information required for regulatory submissions.Ensure documents comply with regulatory and business guidelines in terms of content, format, style,… more
- Merck & Co. (Rahway, NJ)
- …in quality, efficiency, and productivity across the organization. Keeps abreast of project management , clinical data standards, and regulatory requirements ... the Senior Director, Operations and Reference Data Management , ensures project delivery alignment with established... or 5+ years' experience in project management .2+ years' experience working in clinical development… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …around rare diseases and immune disorders.Summary This position is responsible for providing project management , drug development expertise to Global Project ... for partnering with the Global Team leader as the Project Management lead on drug development projects....proposals and stage gate proposals for formal presentation to senior management .Is comfortable working independently within a… more
- Merck & Co. (North Wales, PA)
- …realize its full potential. The Associate Director is expected to provide project management leadership and drive cross-functional teams with sufficient ... influence and mastery of project management to take on challenging assignments...they need.Providing mentoring, coaching, and oversight to Specialist and Senior Specialist project managers working on common… more
- Merck & Co. (Rahway, NJ)
- …collaboratively in a matrix organization with all groups within GCTO, especially with Clinical Sciences and Study Management (CSSM), Clinical Quality ... resourcing for the company's internal clinical trial portfolio.Partner with Clinical Research Organization (CRO) Senior , Regional and local team to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …rare diseases and immune disorders. Summary This position is responsible for providing project management , drug development expertise to Global Project Teams ... project or be partnered with a more senior project manager in support of a...resolve. Leverages their network to influence across the organization.Manages project status in the project management… more
- Merck & Co. (North Wales, PA)
- … clinical regulatory writing portfolio. With minimal oversight, the Senior Medical Writer:Demonstrates independence in preparing clinical regulatory documents ... Job DescriptionThe Senior Medical Writer is responsible for developing medical...cross-functional teams while demonstrating an understanding of team and project leadership responsibilities.Applies knowledge of clinical development,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …at a project level, and interacts with regional and global project team members, senior management , and outside vendors.ResponsibilitiesResponsible for ... drug development plans, serves as QCP subteam leader / clinical pharmacology project team representative, supports Phase... team members, and to a limited extent with senior management and outside vendorsMentors more junior… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …private & public channels Have strong interpersonal; communication; analytical and project management skills Ability to translate strategies into measurable ... Mature Business Unit - Head. Interacts frequently in collaboration with internal management and senior level managed markets customer representatives. Interacts… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and International Conference on Harmonization (ICH) guidelines. Key focus is on providing clinical trial management support to study teams and tracking CRO and ... and immune disorders.Summary Assist in planning and execution of clinical studies, under the supervision of the Study Manager...other vendor performance against project goals and milestones to monitor and ensure compliance… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …global study and project team members, and to a limited extent with senior management , and outside vendors; works independently for all phases of studies ... for all aspects of clinical pharmacology and biopharmaceutics studies; clinical pharmacology project lead; supports Phase 2/3 clinical … more
- Eisai, Inc (NJ)
- …PCS, protocols, and protocol amendments often acting as the compound leadLead project management for medical writing deliverable by defining milestones, managing ... we want to hear from you. Job Summary The Senior Manager, Medical Writing will be the designated Lead...incumbent ensures timely completion, accuracy and quality of all clinical and submission documentation across all aspects of the… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and focus to agreed strategy; Coordinates clinical activities across the project ; Represents IPT to Sr. ManagementPeople Management : Leads large study or ... regulatory agency meetings, if applicable; Defines study strategy across clinical trials within an indication or project ;...representative or IST leader on study team; Responsible before senior management for the creation and execution… more
- Eisai, Inc (NJ)
- …Essential Functions Oversee outsourcing requirements for phase I-IV global clinical trials including functional services.Accountable for vendor management ; ... Suite with a good understanding of other IT systems for contract management and clinical development.#LI-TS1Eisai Salary Transparency Language:The base salary… more
- Merck & Co. (Rahway, NJ)
- …relevant work experience.- Required Skills and Experience :Prior supervisory and project management experiences are necessary.Solid knowledge of statistical ... developing and coordinating statistical activities supporting drug/vaccine projects.Interacts with Clinical , Regulatory, Statistical Programming, Data Management , and… more
- Merck & Co. (North Wales, PA)
- …communication skills (written and oral) in addition to results-oriented project management skills Preferred experience and skills: Deep clinical expertise in ... Job DescriptionRole Summary:The Global Senior Director Medical Affairs (GDMA) Immunology/Pipeline & Biomarkers...as an impactful member of Product Development Team sub-teams ( Clinical , Value Evidence, Commercial, Publications and Label) and Global… more
- Catalent (Harman, WV)
- Senior Director, Supply Chain Position Summary: The Senior Director, Supply Chain is responsible for leading the supply chain organization for Catalent Maryland. ... suites coming online.Reporting to the Vice President and General Manager, the Senior Director Supply Chain directs all facets of supply chain management… more
