- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and authoring reports and co-authoring primary and secondary sections of regulatory documents . The Manager , Clinical Pharmacology is expected to identify, ... setting, to drive the development of potential products and drug candidates. The Manager , Clinical Pharmacology will support or take the lead on generation of study… more
- Aequor (Swiftwater, MN)
- …work in a team environment, effectively interacting with others. Review current documents - incorporate comments from Manager . Navigate through pasteur EDoc ... and review change control documentation. Assist with the editing of quality documents (SOP's, guidelines, validation master plans, etc.) to ensure compliance with… more
- Genmab (Plainsboro, NJ)
- …to fulfilling our purpose.The RoleThe Global Regulatory Labeling Strategy Sr Manager /Associate Director will be responsible for leading the development and ... maintenance of global labeling documents (eg, Core Data Sheet, USPI, EU SmPC and...Labeling Working Group (LWG) to develop and maintain labeling documents including Company Core Data Sheets (CCDS), Core Safety… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary The Assistant Operations Manager will work under the direction of the Operations Manager to provide oversight and administrative support while ... with cGMP, safety standards and good housekeeping standardsAssist Operations Manager in supervising daily operations Determine staffing requirements, work assignment… more
- Novo Nordisk Inc. (Durham, NC)
- …NNPILP and corporate policies. While posted as an Associated level, this a manager position responsible for leading a team within a growing quality department. ... Relationships Senior Manager . Essential Functions Lead team in successful execution of...on assigned area of accountability Responsible for ensuring department documents are current and standardized Support training planning and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. Job Summary: The Manager , Medical Coding is accountable for delivery of medical coding services for ... conventions as applicable for the therapeutic area/indication. Reviews/approves study-related documents pertaining to medical coding requirements such as eCRF… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …other research areas centered around rare diseases and immune disorders. Summary The Manager , Data Programmer is a member of the Biostatistics and Data Management ... SDTM domain output in accordance with SOPs, SOIs, and guidance documents .Manage external vendors and ensure accurate and high-quality deliverables. Ensure… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …government reporting requirements, ensuring accuracy and compliance Organizes department documents , manages all analytics and automation projects, and tracks ... progress, primarily related to government reporting requirements Implements and oversees automation processes to improve data reviews and data quality for ensuring government obligations Tracks all policy and contract template updates as they relate to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …development plans, protocol profile, protocol, and clinical sections of submission documents under guidance of CSL and/or Medical Monitor. Represents Clinical ... Development on Study Team and collaborates as team member with other functions, ARO, CRO. Provides scientific input to Clinical Operations and other functions. This position provides critical support to the CSL and Medical Monitor in the execution of Clinical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …coordinates with E&C monitoring, auditing, and investigations teams, as needed Documents all activities as appropriate in accordance with E&C department expectations ... Maintains current understanding of laws and regulations applicable to pharmaceutical compliance, along with recent trends and changes, and assists with interpretation of state and federal law from a compliance perspective Maintains effective lines of… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- The SQE Manager , QA Compliance, is responsible for managing the Supplier Quality Program at Exela ensuring timely completion of associated activities and ensuring ... of pharmaceutical production in compliance with all CFR, USP, cGMPs, and SOPs. SQE Manager , QA Compliance will rely on experience and judgment to plan and accomplish… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …and support for the business aspects of those functions. Prepares legal documents such as contracts, correspondence (eg, to regulatory agencies), both independently ... Division of the Company. [Specific assignments to be determined by direct manager of the role.]- Creates, implements, and presents training programs and materials… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the US and globally as assigned. [Specific assignment to be determined by direct manager of the role. Global Human Resources (including Benefits) Acts as the legal ... for Global Information Technology/DX, providing legal advice, preparing legal documents , negotiating contracts, assessing security and technical provisions. Advises… more
- Merck & Co. (Durham, NC)
- …the lives of people globally. In this role you will be a project manager that drives the execution of production objectives, while creating an inclusive culture that ... deviation generation rate. Author, review, and/or edit procedures and technical documents to support regulatory filings including standard operating procedures, job… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …aspects of drug development plans with minimal supervision and contributes to documents submitted to Health Authorities globally with some supervision. This position ... team on all aspects of statistical activities; collaborates closely with data manager to ensure high quality data.- Drug Development Strategy: Provides input to… more
- Merck & Co. (Durham, NC)
- …execution and review of GMP documentation such as IQ, OQ and other technical documents to meet schedule milestones. Provide QA shop floor support on batch review, ... meet performance objectives. Consults on an as-needed basis with next level manager on more complex decisions. - Education Minimum Requirement: Bachelor's Degree in… more
- Merck & Co. (Durham, NC)
- …the lives of people globally. In this role you will be a project manager that drives the execution of production objectives, while creating an inclusive culture that ... and decision-making. Author, review, and/or edit procedures and technical documents to support Operations and regulatory filings. Work alongside operations… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Job Responsibilities: Assist with the creation/editing of work instruction documents Assist with the development of training presentations and training ... required Assist and support the Director of Learning & Development, Training Manager , LMS Administrator and Training Supervisors as directed Perform any other duties… more
- Aequor (West Greenwich, RI)
- …days in one week and two (2) working days the following week Notes from Hiring Manager Intake: What location will this role be tied to? 100% ONSITE in 's Rhode ... applicable regulations. Performs review and approval of cGMP processes, procedures, documents and records. Review logbooks, batch records, attachments, work orders,… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Product Supervisor will report directly to quality upper management, (QC Senior Manager ), and will provide both managerial and scientific (hands on) leadership as ... in-process, method transfer, release, and/or stability testing.Reviews and approves documents to release of components, raw materials and drug products.Provides… more
