- Merck & Co. (North Wales, PA)
- …to successfully engage senior leaders in governance meetings and health authority interactions.. Preferred Experience and Skills: Experience in application ... cross-functional leadership to optimize efficiencies in the clinical development space. Preferred skills include experience in the application of AI, machine… 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
- 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
- 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
- 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
- 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 ... Neurology, Neuroradiology, Patent Writing, Persuasion, Professional Networking {+ 5 more}- Preferred Skills:Job Posting End Date:08/16/2025 *A job posting is… 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 ... lead develop key questions and company positions related to CDx for Health Authority interactions (for both sponsor and partner side) CDx RA Policy and Intelligence… 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. (Rahway, NJ)
- …Requirements - One of the following (advanced degree is preferred ):BS/ BA degree in Mechanical Engineering, Biomedical Engineering, Industrial and ... and business goals across stakeholders. Able to influence without formal authority ; ability to influence and present ideas to senior leadership.Motivation and… 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, ... Travel Requirements: 10%Flexible Work Arrangements:HybridShift:Not IndicatedValid Driving License:NoHazardous Material(s):n/aRequired Skills:- Preferred Skills:Job Posting End Date:08/15/2025 *A job posting is… 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 ... a biological science, engineering, or a related field (advanced degree preferred ). Fields of study include Pharmacy, Chemical Engineering, Biology, Microbiology, or… more
- Genmab (NJ)
- …regulatory environment, including surveillance of changes in major health authority guidances and regulations, trends, and regulatory developments.Manage process for ... effortsRequirementsBachelor's degree in a scientific discipline is required; PharmD/PhD preferred .3-5 years of pharmaceutical industry experience preferred ,… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …experience with patient affordability offer-related programs and/or related experience highly preferred Proven customer service or related experience preferred ... Management and Quantitative analysis skills Ability to lead and influence without authority and navigate within a matrix environment Strong Microsoft Excel and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …is required. Finance, Business, Statistics, Engineering or related quantitative field preferred A Master of Business Administration (MBA) is preferred ... managed markets insights is required Ability to lead without authority /reporting relationship required Analytical and/or technical proficiency at analyzing large… 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 ... Leadership, Physiology, Program Management, Regulatory Affairs Compliance {+ 4 more}- Preferred Skills:Job Posting End Date:08/4/2025 *A job posting is effective… 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 ... improvement Industry Knowledge Experience in AI/GenAI application development for healthcare is preferred The base compensation range for this position is $ 181,670… more
- Eisai, Inc (Nutley, NJ)
- …meetings with other Health Authorities the CDE. Actively participates in Health Authority GCP inspections (eg, FDA, EMA, PMDA) including responding to observations ... study in a scientific discipline with a Master's or other advanced degree preferred . Position involves line management responsibility for personnel in US and UK and… 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 ... Bachelor's degree in an associated functional discipline (advanced degree preferred ) with minimum 12 years in clinical research/ operations/ data… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …maintenance, simple negotiations, prepares for audits and inspections, maintains preferred supplier list, maintains and tracks Procurement training for compliance, ... for internal approvals and signatures, based on amount and signing authority ; create Purchase request from executed contract; and update CLM system/trackers… more
