- Exela Pharma Sciences, LLC (Lenoir, NC)
- Position Summary:The Prep Technician is responsible for assisting with executing prep activities ( prep comprises getting the production team ready by ... production paperwork Assist with line clearance/changeovers and cleaning for the prep processMaintain personal training compliance status and work in compliance with… more
- Aequor (Fort Worth, TX)
- …updated information regarding domestic or international laws, guidelines, or standards. * Prepare or direct the preparation of additional information or ... documentation databases or systems. * Coordinate efforts associated with the preparation of regulatory documents or submissions for medical devices (US, EU… more
- Merck & Co. (Durham, NC)
- …the position will focus on microbiology and sterility testing readiness in preparation for commercial production.- The selected candidate will initially work on ... project team initiatives to ensure timelines are met and laboratories are prepared for routine product testingRESOURCE MANAGEMENT: Aware of costs and assists in… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Centre. Provide clients with best-in-class guidance in event coordination. Execution preparation , and day-of coordination, addressing client needs promptly in the ... and onboarding new staff members and freelancers to ensure they are prepared for success Physical Requirements There is no overnight travel required. Must… more
- Merck & Co. (Rahway, NJ)
- …and other documents for filing-Review notice of allowance and file history; prepare documents for internal review, including the preparation of allowed ... of tasks to be handled by the paralegal; independently draft and/or prepare simple to moderately complex legal documents including "shell" amendments (requests for… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …serve as the Labeling Project Lead. This position leads labeling meetings for preparation of responses to comments from HAs, meeting required timelines to achieve ... through direction of a team of GLLs, manage, develop prepare and implement regulatory documents (eg, draft launch labeling,...development or approval for either the US or EU. Preparation of updated Core Data Sheets, and EU and… more
- Genmab (NJ)
- …selection, feasibility assessment and engage in KOL interaction Prepare charters and coordinate internal/external committee meetings including presentation ... preparation (ie, Dose Escalation, DMC, Steering Committee, Safety) Participate...serve as a liaison to project teams and CROs Prepare presentations for Investigator meetings, CRO/CRA training, SIVs as… more
- Insmed Incorporated (San Diego, CA)
- …internal teams, contract research organizations (CROs), and external vendors to prepare , review and finalize clinical study documents and plansContribute to ... assessing medical monitoring reports, study integrity/conduct, and study oversightSupport preparation of abstracts, manuscripts, presentations, and materials for meetings… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …robust development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support across ... meetings for assigned product. Liaise, negotiate and orchestrate meetings with FDA. Prepare internal meeting minutes to capture the full discussion for archiving.… more
- Novo Nordisk Inc. (WA)
- …contracts for external consultants and invoicing. Contacts involve planning and preparation communications to internal and external partners, require skill, tact, ... ensure budgetary compliance with accounting Develop budget, track budget expenditures, prepare RE2 submissions, process expenses, and accruals, etc. Tracks budgeting… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …serve as the Labeling Project Lead. This position leads labeling meetings for preparation of responses to comments from HAs, meeting required timelines to achieve ... through direction of a team of GLLs, manage, develop prepare and implement regulatory documents (eg, draft launch labeling,...Independently or through oversight of a team of GLLs, prepare labeling documents for review. Lead review processes to… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …robust development plans. The individual will direct, coordinate and implement the preparation of US regulatory submissions and provide US regulatory support; meet ... and implement US regulatory strategy for assigned project. Lead and prepare FDA submissions, including but not limited to briefing documents, breakthrough… more
- Merck & Co. (Rahway, NJ)
- …facilitate project meetings, ensuring agendas are set and pre-work for workshops is prepared and effectively lead discussions to ensure groups don't lose focus on ... real priorities.Required Experience and Skills: Bachelor's degree in computer science, data science, life science, business administration, or related fields.3+ years in Project and/or Program Management supporting Information Technology, or Pharmaceutical… more
- Merck & Co. (Rahway, NJ)
- …management pathways), including their own role.- The position is responsible for disclosures prepared within the group to be used as the basis for external ... publications and filings.- The role will also be responsible for proactive resourcing planning, risk assessment strategies and budget management as necessary.Maintaining an effective network internally and across the external academic and regulatory community… more
- Aequor (Devers, TX)
- …experience following and documenting written instructions is required.Committed team player prepared to work in and embrace a team-based culture.Shift work and ... overtime required. Additional InformationWork in a cGMP laboratory and/or manufacturing environment following techniques that require maintaining a high attention to detail.Properly use Personal Protective Equipment (PPE), gowning for restricted areas, aseptic… more
- Aequor (Devers, TX)
- …experience following and documenting written instructions is required.Committed team player prepared to work in and embrace a team-based culture.Shift work and ... overtime required. Additional RequirementsSelected candidates will be required to enter a structured training program and successfully complete all modules, including: Biologics orientation trainingGeneral knowledge trainingJob function training Candidates… more
- Merck & Co. (Durham, NC)
- …support to B160 Operations areas (sterile supply, weigh/dispense, media, stabilizer/ prep , Drug substance, filling, capping/inspection, clean utilities etc.) located ... in aseptic and clean room environments.- Works within a team to perform maintenance and troubleshooting activities.- Completes complex maintenance tasks, resolves deviations and evaluates equipment performance.- Follows proper procedures for maintaining… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the Legal & Corporate Affairs Department, including but not limited to independent preparation of legal documents which may include AOPs and AOIs, completion of ... and across the Company.- Licensing and Annual Reports: Responsible for the preparation , processing, filing and maintenance of all distribution and business license… more
- Lovelace Biomedical Research Institute (Albuquerque, NM)
- …methods, policies and principles are being followed. Oversees the calculating, preparation , posting and approvals of invoices and journal entries. Assist with ... audit. Serves as primary point of contact with external auditors including preparation and review of audit schedules and support. Prepares and reviews monthly… more
- Merck & Co. (Rahway, NJ)
- …all supporting/backup files createdResponsible for optimization, standardization and preparation of all collaboration deliverables (data workbooks, shareable ... review of actuals reporting (accrual, true-up, reconciliation, payment and disclosure preparation )Act as the primary finance point of contact for all Global… more
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