- Daiichi Sankyo, Inc. (Bernards, NJ)
- …options with supervision, and this position acts as the company liaison with the Health Authority (eg, US FDA and EU EMA) for assigned projects with support, on CMC ... matters. This position supports Health Authority Meetings (eg, preIND, EOP2, pre-NDA, Type C, Scientific Advice) with supervision, from preparation of the briefing… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and customer focus. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements in relation to Pharmacovigilance (PV) ... deviations to ensure alignment with NN requirements and external health authority regulations Develops comprehensive, relevant resources (eg training program, FAQs)… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and customer focus. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements in relation to Pharmacovigilance (PV) ... and system development in a manner consistent with global affiliate health authority and/or stakeholder requirements Participates and or provides support to audits… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …audit program and effective CAPA management resulting from audits, health authority inspections across the organization and affiliates as appropriate for the ... Pharmacovigilance (CSPV) and post marketing stakeholders for key Health Authority pre-approval and sponsor-monitor inspections; provide inspection management support… more
- Genmab (NJ)
- …protocols, investigator's brochures, and clinical study reports.Contribute to Health Authority briefing documents and responses, and clinical modules of regulatory ... reports. Senior level candidates should also have knowledge of Health Authority briefing packages, Health Authority responses, and Pediatric Investigational… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …with the creation of contingency/backup plans for CDx submission. Health Authority Submission Preparation : Assist with preparation of pre-submission documents and ... questions and company positions related to CDx for Health Authority interactions (for both sponsor and partner side) CDx...to travel up to 10% Occasional travel to Health Authority meetings in US and Europe, potentially Japan Daiichi… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …to patients. This role enables and ensures compliance against health authority regulations and Novo Nordisk requirements in relation to Pharmacovigilance (PV) ... and system development in a manner consistent with global affiliate health authority and/or stakeholder requirements Participates and or provides support to NAO… more
- Merck & Co. (North Wales, PA)
- …the statistics department at internal governance meetings, health authority meetings, advisory committee meetings, and statistical conferences, showcasing ... to successfully engage senior leaders in governance meetings and health authority interactions.. Preferred Experience and Skills: Experience in application of AI,… more
- Formation Bio (New York, NY)
- …and alignment across cross-functional teams, influencing without direct authority . Manage complex stakeholder relationships and balance competing interests. ... You know how to drive accountability and alignment across teams without direct authority . You have 6+ years of experience in program or project management within… more
- Merck & Co. (South San Francisco, CA)
- …to set and manage stakeholder expectations, ability to influence without authority .Ability to work effectively in a matrixed environment, ability to manage ... cross-functional teams.Travel:- up to 25 %Current Employees apply HERE Current Contingent Workers apply HERE US and Puerto Rico Residents Only:Our company is committed to inclusion, ensuring that candidates can engage in a hiring process that exhibits their… more
- Merck & Co. (Rahway, NJ)
- …skills and a strategic thinker; able to influence without formal authority ; ability to influence and present ideas to senior leadershipExcellent communication, ... presentation, negotiation, project management, and organizational skillsWilling to travelAble to quickly pick up advanced domain knowledgeAble to multi-task continuouslyPREFERRED REQUIREMENTS: Master's degree in one of the above disciplines plus 7 years… more
- Merck & Co. (Rahway, NJ)
- …and business goals across stakeholders. Able to influence without formal authority ; ability to influence and present ideas to senior leadership.Motivation and ... Inspiration: Propels self and others toward higher levels of performance that are aligned with the organization's purpose and goals.- Preferred Experience and Skills: Deep subject-matter expertise in both parenteral and ocular delivery product design and… more
- Tris Pharma (Nashville, TN)
- …and clean driving record REQUIRED Ability to influence without direct authority REQUIREDAnticipated salary range: $100-120K/yr. Base salary offered is contingent on ... assessment of candidate's education and experience level relative to requirements of the position and a review of related industry standards and internal equity.Additional benefits: In addition to base salary, full-time employees are also eligible for… more
- Merck & Co. (Upper Gwynedd, PA)
- …original NDA/MAA, agency background packages and responses to health authority questions per established business processes and systems.-Identify, communicate and ... escalate potential regulatory issues to GRACS CMC management, as neededDemonstrate an understanding of regulatory affairs and apply this understanding to the benefit of the company to ensure the approval and launch market supply of our company's pharmaceutical… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …Management and Quantitative analysis skills Ability to lead and influence without authority and navigate within a matrix environment Strong Microsoft Excel and ... PowerPoint skills required Planning, Execution and Follow-up - effectively prioritizes and spends time, and the time of others on what is important Strong interpersonal/communication skills The base compensation range for this position is $116,810 to $216,100.… more
- Genmab (NJ)
- …regulatory environment, including surveillance of changes in major health authority guidances and regulations, trends, and regulatory developments.Manage process for ... dissemination of regulatory intelligence and subsequent impact assessment within GenmabWork closely with the global regulatory leads (GRLs), regional regulatory leads (RRLs) and global labeling leads (GLL) to support ad-hoc queries, providing novel insights to… more
- Merck & Co. (Rahway, NJ)
- …Prioritizes and oversees execution of high quality and timely health authority engagement in attaining desired results. Reviews and defends stage-gate deliverables ... for programs including risk assessment and mitigation plans and engages in corporate governance meetings overseeing the progress of those development programs.Inspires a high level of performance in a dynamic environment, leaning into areas of talent… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …managed markets insights is required Ability to lead without authority /reporting relationship required Analytical and/or technical proficiency at analyzing large ... data sets to derive insights Comfort operating in a fast-paced, environment, with a quality control focus and a documentation orientation Creative problem-solving with ability to solve complex unstructured problems; see opportunities through Experience… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …collaboration skills with clear ability to impact and influence without authority Excellent at presenting complex technology concept to senior stakeholders Creative ... problem-solver with a track record of process improvement Industry Knowledge Experience in AI/GenAI application development for healthcare is preferred The base compensation range for this position is $ 181,670 to $ 317,920. Base compensation is determined… more
- Eisai, Inc (Nutley, NJ)
- …vendors, clinical documents, and internal process audits Facilitate Sponsor health authority inspections of global clinical facilities and study sites Continuously ... drive innovation through active search, evaluation, acquisition, and implementation of high-impact new technologies/ procedures across clinical quality programs Direct skill-building interventions for CQA staff through cross-functional/ external partnerships… more
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