- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …in R&D as early as possible. This led us to create the Translational Patient Safety Senior Director position, which will have unique exposure to Daiichi Sankyo's ... Job SummaryTo succeed as global pharma innovator in oncology, a therapeutic area known for accelerated development and approval with smaller numbers of subjects… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Senior Clinical Director (Sr. Principal Scientist) has primary responsibility for the strategic planning and directing clinical research ... With a focus on late-stage development, the Senior Clinical Director will manage the entire cycle of clinical development,...the clinical findings from studies to support decisions regarding safety and efficacy as well as new drug applications,… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionThe Associate Director , ESQL is responsible for all activities at the External Entity (EE) site associated with the manufacturing of company products ... all applicable regulatory requirements, regulatory filings and company policies.The Associate Director also ensures that effective and robust Quality systems are… more
- Merck & Co. (Rahway, NJ)
- …to GRACS.Primary activities include, but are not limited to:Reports to Executive Director or Associate Vice President, Therapeutic Area Lead.Develops worldwide ... to the world.Looking for someone with a growth mindset. The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory strategy for their… more
- Merck & Co. (Millsboro, DE)
- Job DescriptionPosition Description: Associate Director - Site Digital Technology Lead The Site Digital Technology Lead is the representative for Global Animal ... and that all operational activities are compliant with regulatory, safety , cyber-security, business continuity and financial requirementsLeadership of site digital… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at the study ... of data is suitable for regulatory submission. The Associate Director will have routine interaction with key internal and...writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.Lead the CRO and vendor selection… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …future capabilities. We're responsible for regulating accounting, upholding workplace safety , managing our supply chain and sampling, supporting technological and ... date with the latest methodologies and insights. Relationships Reports to the SR Director Sales Reporting & GtN. Internal relationships include Senior HQ & local… more
- Eisai, Inc (NJ)
- …programs within the Medical Affairs department for products in the therapeutic area . The Medical Director utilizes expert medical/scientific knowledge in ... profile, we want to hear from you. The Medical Director , US Medical Affairs provides medical leadership for medical...affairs strategy, planning and supportive tactics for assigned therapeutic area . This role is responsible for working with key… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to ... of protocol deviations- Discusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management of adverse… more
- Eisai, Inc (Nutley, NJ)
- …for assigned therapeutic area . Under the direction of the Senior Medical Director , this role will be responsible for working with key stakeholders to develop and ... programs within the Medical Affairs department for products in the therapeutic area . The Medical Director will utilize expert medical/scientific knowledge in… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …for managing the multiple Clinical Science Asset Leaders (CSALs) at the Senior Director level for each respective programThis Clinical Science (CS) Group Lead will ... clinical data review excellence with a focus on patient safety and data integrity, site scientific engagement, and HA...SCOREAs a core or extended member of the Disease Area Strategy Team (DAST), the CS Group Leader will… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …study; Consults with KOLS for advice on complex development or safety issuesScientific, Program related: Integrated Study Team (IST) representative or IST ... non-study related activities: Provides input on KEE selection for Therapeutic Area ; Reviews content to be shared with KEEs; Frequent involvement in… more
- Insmed Incorporated (Bridgewater, NJ)
- …Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Director , Clinical Development will play an important role in working with the ... analysis or blinded data reviews.Production of tables, listings and narratives of safety areas of interest/focus: eg MACE, Potential events related to metabolite,… more
- Insmed Incorporated (Bridgewater, NJ)
- …external stakeholders (therapeutic areas, clinical pharmacology, clinical operations, non-clinical safety , contract research organizations etc.) to build and to ... in the pharmaceutical, CRO or related industry within bioanalytical area across various modalities.Demonstrated method development and validation experience with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Collaborates with CSPV to ensure monitoring / reporting of AEs/SAEs, Reviews safety reports/data during study conduct, Provides and documents oversight of medical ... Provides medical direction to MW for the CSR; Working with Clinical Safety Pharmacovigilance (CSPV), defines product level surveillance plan and interpretations, eg… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …maintains constructive and positive interactions with colleagues. Essential Functions Therapeutic Area : Assist Manager/ Director in review of labeling for ... needed. Relationships Reports to a Manager, Senior Manager, Associate Director or Director . Works with personnel in...Reports, NDA Annual Reports & Annual ADE Reports, IND Safety Reports, Drug & Establishment Listings, responses to FDA… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This position may require ... writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.Lead the CRO and vendor selection...share with study team, Operations Program Lead, and Sr. Director for the compound, on regular basis and ensure… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …specific focus on infrastructure, budget and non project initiatives. The Senior Director , Global Head of CR2 Project Management & Operational Excellence is ... a culture of innovation across the whole organization, encouraging psychological safety and agile methodology to boost creative thinking and continuous improvement-… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionPosition Description: HVAC Operations Manager Reporting to the Associate Director in HVAC, the HVAC Operations Manager will be part of the 24-hour ... and embraces our team culture including significant interaction with operations, safety , automation, and other groups as necessary. This Position sits in… more
- Merck & Co. (Rahway, NJ)
- …responsibility.The Associate Specialist -Operations Support position will report to the Associate Director , Engineering and will be a member of the EF Team at ... is compliant with various site requirements (eg, environment and safety ) and other regulations as needed, and that the...to ensure that the facility runs smoothly. A specific area of focus will be the PAT (Process Analytical… more
