- Merck & Co. (North Wales, PA)
- …and being recognized for having - deep subject matter expertise in the relevant guidance , policies, codes, and regulations, as well as in their applications to the ... when supporting line management in the development of new or refined guidance to ensure that they are relevant, appropriate, and implementable.- Steps include… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …the Global Medical Director(s) to develop a broad range of medical guidance documents while adapting to needed digital solutions (eg e-learnings) Ensures alignment ... of relevant cross-functional medical guidance activities/platforms on specific product/project Publication Planning: Support the development and execution of… more
- Merck & Co. (Rahway, NJ)
- …incidents and perform investigation, containment, and remediation efforts.Provide guidance to first-level responders for handling cyber security incidents.Develop ... a defined review process, providing in-depth analysis, actionable insights, and guidance to improve response and enhance overall incident management effectiveness.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …advancing the mission of our organization by providing strategic medical expertise, guidance , and vision in the development and execution of our global development ... our products in outcome studies Develops a broad range of medical guidance documents while adapting to needed digital solutions (eg e-learnings) Ensures alignment… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …The Scientific Global Medical Director will provide leadership, direction, and guidance for the development and implementation of medical and scientific strategies ... our products in outcome studies Develops a broad range of medical guidance documents while adapting to needed digital solutions (eg e-learnings) Ensures alignment… more
- Merck & Co. (Durham, NC)
- …are guided by policies, procedures and business plan; receives occasional guidance from manager.Provides planning and scheduling guidance to mechanics ... cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".… more
- Merck & Co. (Durham, NC)
- …are guided by policies, procedures and business plan; receives limited guidance from manager.Provides planning and scheduling guidance to mechanics, ... cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …claims and marketing messages and providing proactive recommendations and/or guidance for alternative data/references/language where needed Assures team reviews, ... in relevant internal and external meetings and trainings on new guidance /regulations, new scientific information, and marketing strategy Remain current with medical… more
- Genmab (Plainsboro, NJ)
- …publication/communication plans in a timely and efficient manner.Provide leadership, guidance , and strategic oversight to team members, including direct ... landscapes, fast paced, and tight timelines.Understanding of good publication practices and guidance (GPP, ICMJE), and other guidance related to scientific data… more
- Merck & Co. (Rahway, NJ)
- …and performance improvement the senior specialist will provide direct guidance , planning and supervision.- The selected candidate will ensure understanding ... cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".The… more
- Merck & Co. (North Wales, PA)
- …CMC Regulatory Affairs, to address technical challenges, provide scientifically sound guidance at each stage of development, and effectively manage deliverables to ... cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".… more
- Merck & Co. (North Wales, PA)
- …CMC Regulatory Affairs to address technical challenges, provide scientifically sound guidance at each stage of development, and effectively manage deliverables to ... cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".… more
- Legend Biotech USA, Inc. (Raritan, NJ)
- …coordinate with other teams to complete projects in a timely mannerProvide guidance to Quality Leaders about handling of various nonconformances and strategies for ... requirementsReview and approve change controls in relation to QA Laboratory ComplianceProvide guidance to QALO and QA Laboratory Compliance teams as well as… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …corporate goals.The role will be accountable for coordinating, mentoring, and providing guidance to direct reports (US RA strategists) across the alliance products ... archiving.Serves as US RA strategy SME and coordinates, mentors/instructs, and provides guidance to direct reports (US RA strategists) across the alliance products… more
- Merck & Co. (Durham, NC)
- …challenges.Decisions are guided by policies, procedures, and business plan; receives guidance from manager.Provides technical guidance to employees and ... cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".… more
- Merck & Co. (Rahway, NJ)
- …3D printing) for fixture development and device redesign efforts. Fluency with industry-related guidance & standards: 21 CFR Part 421 CFR 82021 CFR 210/ 211EU ... Medical Device RegulationUSP USP FDA Guidance for Industry, Container Closure Systems for Packaging Human...met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have… more
- Genmab (Plainsboro, NJ)
- …key opinion leaders Participate in review of and comment on regulatory guidance as relevant As assigned by management, provide regulatory due diligence assessment ... and scientific subject matter as well as evolving regulatory policy and guidance Ability to work well within cross-functional teams Strong communication skills -… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …protocol profile, protocol, and clinical sections of submission documents under guidance of CSL and/or Medical Monitor. Represents Clinical Development on Study ... Clinical Development functions. Responsibilities: Study Strategy: Drafts development plan under guidance of CSL and/or Medical Monitor. Contributes along with CSL… more
- Merck & Co. (Rahway, NJ)
- …and life cycle management to independently provide day-to-day coaching/ guidance to individual contributorsMaintaining a comprehensive understanding of global ... cannot be reasonably met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have been designated as "remote".The… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …copay program strategy in collaboration with marketing colleagues. Provides strategic guidance on how to balance these investments across the franchise Supports ... and long-term strategic planning by providing future access and ARP/rebate guidance and potential financial implications. Leads anchor budget and long-term forecast… more
