- Daiichi Sankyo, Inc. (Bernards, NJ)
- …Possesses in-depth knowledge of regulatory authority's requirements.Typically has administrative responsibility for recruiting, retaining, developing, and managing ... compliant with regulatory requirements, including CDISC ADaM data set specifications, reviewer 's guides, etc.- Global Biostatistics Data Management (BDM) Strategy to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …development initiatives. The Program Lead will have direct accountability for administrative deliverables, will interact regularly with senior leadership and will ... OLT with assessing portfolios, preparing documents and communications, and conducting a final review of materials prior to OLT submission. This position acts as a… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and resolving matters of confidentiality. Coordinating a budget planning and review meeting with Finance Business Partner, Function Head and stakeholders. Partner ... budget.- Establishes and maintains internal policies and procedures for administrative activities. Implements work plans and initiatives.- Develop, maintain, and… more
- Merck & Co. (Rahway, NJ)
- …- R eview notice of allowance and file history; prepare documents for internal review , including the preparation of allowed claims and payment of issue fee - ... are properly named and saved in the IP Group's document management system Review contents of patent application files to check for compliance with USPTO requirements… more
- Merck & Co. (North Wales, PA)
- …and regulatory submissions including assisting in preparing submissions, protocol review , and conducting research on regulatory guidances or competitive ... also assist or take the lead in tracking, authoring, shepherding and/or review of responses to Agency requests.Implements strategy to develop agency background… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …key study documents to the CRO and vendors as appropriate.Provide clinical administrative support to the study teams. This may include preparing meeting logistics, ... post trial information on required public forums (eg.clinicaltrials.gov).Under supervision, review and document CRO-generated reports, such as site monitoring trip… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and implementer, planning and directing key marketing operational, financial, and administrative activities. This role is also responsible for ensuring preparedness ... operations. This role includes overseeing the marketing materials planning and review process, management of internal agency's operations, and facilitation of POA… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …QA relevant activities including QQR, monthly quality report, team building and management review .- Involve and attend the Global QA relevant meeting and create the ... activities (eg, e-mails)- Create the weekly QA communication e-mail- Administrative support includes but not limited to: Responsible for...to the system and information to do that work.- Review the QA onboarding business slides edits and updates… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …on quality, reliability, consistency and efficiency.ResponsibilitiesPlan, coordinate, and review US regulatory submissions in collaboration with USRL, Regulatory ... complex Module 1 regulatory documents (eg cover letter, FDA forms, administrative information, letter of authorization, etc.) for US regulatory submissions.Support… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …RD/PV QA relevant activities including Business Plan, QQR, team building and management review .Involve and attend the Global QA relevant meeting and create the draft ... activities (eg, e-mails)- Create the QA Newsletter with Team- Administrative support includes but not limited to: Responsible for...to the system and information to do that work.- Review the QA onboarding business slides edits and updates… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …teams and supported functional areas.Meet with Sales Leadership on a regular basis to review processes and gain insight of the field needs with goal of enhancing ... Meetings with stakeholders and cross-functional teams, agencies, and partners to review all congress initiatives, timelines and deadlines for content and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …unmet needs & payer value story, working with an agency, learning the Promotional Review Board (PRB) process and usage of VEEVA, developing & testing value messages, ... on payer value communication and market access. Adheres to administrative policies and procedures. Physical Requirements 0-10% overnight travel required.… more
- Aequor (South San Francisco, CA)
- …leads to focus on strategy and execution rather than time-consuming administrative tasks. Driving Operational Excellence: Serving as a dedicated resource with ... to streamlined Health Care Provider (HCP) self-service contracting processes. Ensure timely review and approval of contracts and ensure the on-time issuance of POs.… more
- Merck & Co. (North Wales, PA)
- …conduct statistical research and other non-project activities.Performs managerial, administrative duties including coaching, performance evaluation, expense report ... sound and meet worldwide regulatory and marketing needs.Perform comprehensive review of protocols, statistical analysis plans, clinical study reports, and… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …emphasis in technical and scientific writing ability is essentialManage the administrative infrastructure of the research, including overseeing the functions of ... grant development/preparation, human research and review committee (HRRC/IRB), Institutional Animal Care and Use Committee (IACUC) office management, operational… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …issues impacting Novo Nordisk profitability of franchise area Leads the yearly review of current pricing strategies and owns the process for developing ... metrics. Regularly reviews current program progress to accomplish goals Adheres to administrative policies and procedures and encourages others to do the same… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …for reviewing unit test plans to ensure all requirements have been met. Review integration test plans and perform integration testing as necessary to ensure that ... and on-boarding of external vendors to accommodate emerging projects and administrative support for the global ERP Applications. Develops strategies to leverage… more
- Tris Pharma (Monmouth Junction, NJ)
- …guidelines; Establishes, oversees implementation, and monitors adherence to administrative policies and procedures; Ensures collaborative and compliant communication ... promotion etc.Deep knowledge of the pharmaceutical Legal, Medical, Regulatory review processDemonstrated experience in driving marketing strategy and market… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …(SOPs), protocols and regulations. The successful candidate will assist in administrative functions of study execution such as labeling collection tubes and ... transporting supplies to appropriate area, quality control review of data, coordinating sample shipment, and acting as shift or study lead. Activities as lead may… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …Manager - Federal Contracts and Compliance will work closely with LBRI administrative leadership and scientific teams to oversee efficient operations of the ... funding, contract and grant issues, the ability to draft, review and approve moderate-to-complex non-routine contractual instruments, and demonstrated knowledge… more
