- Merck & Co. (North Wales, PA)
- …Director demonstrates subject matter expertise in relevant laws, regulations, policies, and guidance , as well as a thorough understanding of client objectives and ... following major activities: Provide independent oversight and high-quality compliance guidance across Corporate Affairs and Patient Innovation & Engagement.- Advise,… more
- Twist BioScience (South San Francisco, CA)
- …providers, and subject matter experts Provide strategic thinking, thought leadership, and guidance on identifying gaps in key controls and design a proactive risk ... align governance programs with the organization's objectives and execute roadmapsProvide guidance , assessment, and oversight on the governance of Change Management… 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
- Novo Nordisk Inc. (Plainsboro, NJ)
- …work with employees across the organization to oversee legal matters and provide guidance on strategies that drive business and policy priorities and shape the ... fraud and abuse laws and regulations, promotional regulations, regulatory guidance , enforcement and litigation activity, competitor actions, consumer fraud, HIPAA,… more
- Merck & Co. (Rahway, NJ)
- …control strategy, and specifications-setting.-Deep working knowledge of regulatory guidance and quality standards, with experience authoring and reviewing ... and Skills: Strong external scientific reputation including publications, regulatory guidance documents, presentations at scientific meetings, membership on (or… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …work with employees across the organization to oversee legal matters and provide guidance on strategies that drive business and policy priorities and shape the ... intellectual property and related corporate and legal issues with minimal guidance . Identifies and aggressively pursues strategies and actions for global patent… more
- Merck & Co. (North Wales, PA)
- …Teams (DCTs) responsible for building and executing CMC development plans. - Under the guidance of the CIPM Director & Portfolio Lead , the core responsibility of ... project management to take on challenging assignments with minimal guidance . Projects could span the full CMC development continuum...met working remotely. Please note, this Hybrid work model guidance also does not apply to roles that have… more
- Merck & Co. (Rahway, NJ)
- …utilities), product equipment operation, vendor management, process safety and industry guidance are preferred.- Candidate should have demonstrated ability to lead a ... of alternative solutions and the development of project scopeProvide technical guidance during project implementation, assure viability of technology in proposed… more
- AUROBINDO (Durham, NC)
- …document scientific experiments; Plan & organize scientific experiments under minimal guidance from more experienced team members. Seeks proactive support and ... raw data; Evaluate and Contribute to interpretation and report results under minimal guidance from more experienced team members; Propose and provide input for the… more
- Merck & Co. (North Wales, PA)
- …and execution of strategies supporting the scientific and payer customer segments, providing guidance and expertise to the teamServe as the subject matter expert for ... and executionMonitor performance against objectives and key results, providing guidance to the team on strategic prioritiesCollaborate with Legal, Regulatory,… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …meetings (development and marketed products); provide regulatory support and guidance and manage day-to-day regulatory activities.Collaborate with all disciplines ... obtain and/or provide information/data for regulatory filings.Mentor/instruct and provide guidance to direct reports.Review and interpret regulatory guidelines.Review RA… more
- Exela Pharma Sciences, LLC (Lenoir, NC)
- …Job Responsibilities: Drafting, editing, and reviewing FDA-issued regulations and Guidance documents, as well as internally developed technical documents, including ... and technical documents, such as regulations, statutes, and regulatory guidance documents. Excellent problem-solving, analytical, investigative and decision-making skillsEffective… more
- Merck & Co. (Irving, TX)
- …employees as well as effectiveness, engagement, accuracy and efficiency.Provide mentoring guidance to all subordinates, management or otherwise, across all aspects ... 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)
- …the Durham site for the Change Management and Quality Management System.Provide guidance to staff for the implementation, management, and enhancement of document ... 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)
- …internal and external stakeholders for assigned therapeutic areas/therapies Provides guidance /conducts training of internal and external stakeholders on publication ... in the correct use of publication systems. Develops/aids in developing guidance documents and process descriptions to improve processes related to publication… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …role will be to generate holistic evidence-based strategic insights and tactical guidance to drive decision making within the cross-functional commercial teams and ... making and develop innovative solutions to unstructured problems with minimal guidance . Relationships Reports to Director, Obesity Insights & Analytics. Internal… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …during the conduct of the study to provide medical inputProvides medical guidance for coding of AEs, medical history, and medications when neededAddresses medical ... support addressing eligibility and medical questions from sites/ IRBsMay provide medical guidance for coding of AEs, medical history, and medications when needed… more
- Merck & Co. (Durham, NC)
- …are guided by policies, procedures and/or business plans.Provides technical guidance to employees, colleagues, or clients.Anticipates and interprets client and/or ... 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)
- …LC-MS, GC-MS and/or ICP-MS. Working knowledge of CMC filing requirements and regulatory guidance 's ( eg , ICH) for API Experience working with CMO's and CRO's ... 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. (Rahway, NJ)
- …team calendars, communications channels, allocation of work, events planning guidance , etc. Oversee operational on/offboarding of HHDDA employees and contractors, ... 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
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