- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …as well as other research areas centered around rare diseases and immune disorders.Summary The Director , Clinical Safety , will be a product safety lead or ... safety team, and be responsible for overall product safety strategy or specific areas of safety ...to strategically manage benefit-risk throughout the lifecycle of the drug . Specific responsibilities will vary depending on the stage… 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 ... actionable insights to guide the business. Relationships Reports to the Director , MAPA Insights. Internal relationships include close interactions with Market Access… more
- 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 ... global drug portfolio from the Research stage to post marketing/lifecycle...within CSPV. He/she will spearhead developing a culture whereby safety is diligently considered prior to selecting promising candidates… 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 ... ready to maximize your potential with us? The Position The Associate Director of Enterprise Functions Insights & Analytics will provide holistic, insight-driven… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …incumbent will help develop multiple products. In doing so, the Senior Medical Director will work across different functional teams to support the design and ... execution of clinical trials, the drafting of medical/ scientific documents, safety monitoring, and data analyses. In this high visibility position, the candidate… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on ... Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and execution at...writing tasks may involve ICF, CRF guidelines, IB and safety communications, DSUR, IND.Lead the CRO and vendor selection… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …research areas centered around rare diseases and immune disorders. Summary The Senior Director , Head Global PV Quality (DSI/DSE) reports to the Global Head RDPVQA, ... with RD and Medical Affairs Quality to provide clinical safety QA advise wherever necessary. Ensure requirements are in...agencies required- 10+years of working knowledge of the end-to-end Drug development process in the R&D space required- 10+… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …employer including veterans and people with disabilitiesSummaryThe Associate Director , Global Oncology Clinical Development (GOCD) Functional Excellence supports ... (AESI) educational materialsThis role works cross-functionally to collect / update safety and treatment information that is ultimately provided to educate patients… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Team (SMT) materials- Supports overall program safety reporting (eg, Periodic Safety Update Reports (PSURs), Drug Safety Update Reports (DSURs), ... areas centered around rare diseases and immune disorders.Summary The Senior Director sits within Global Oncology Clinical Development, an organization dedicated to… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …oncology trials as well as submission-related activities, eg, integrated summary of safety (ISS) and integrated summary of efficacy (ISE)- Direct Project Support: ... guides, etc- Global Biostatistics Data Management (BDM) Strategy to Improve Drug Development: Leads implementation of vision and strategy, and identifies technology… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …oncology trials as well as submission-related activities, eg, integrated summary of safety (ISS) and integrated summary of efficacy (ISE).- Direct Project Support: ... guides, etc.- Global Biostatistics Data Management (BDM) Strategy to Improve Drug Development: Leads implementation of vision and strategy, and identifies technology… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …develop programming submission strategy, perform integrated analysis of efficacy and safety , generate submission data package, create TLFs to support submission QAs, ... and reporting of clinical trials preferred- Knowledge of all phases of drug development, including early and late phase clinical development and submission… more
- Catalent (Philadelphia, PA)
- Position: Director QualityLocation: Philadelphia, PAPosition Summary: The Quality function is to build, monitor, and sustain a robust and effective quality system ... to, good manufacturing practice/quality system requirements of the Food and Drug Administration, state boards of pharmacy, European, South American, Japanese, and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal and external stakeholders. Relationships This position will report to Senior Global Safety Lead/ Director /Senior Director - Safety Surveillance, ... a life sciences/pharmacy nursing degree with 13+ years' experience in global safety surveillance and/or clinical/ drug development Excellent verbal and written… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …within the Global Clinical Science function. This position may be at the executive director level or senior director level, depending on the scope and size ... charter, etc), clinical data review excellence with a focus on patient safety and data integrity, site scientific engagement, and HA responses. Interactions with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on ... primarily a tactical study delivery role, reporting into an Associate Director or above responsible for Operational Study Strategy. Responsibilities:Study Planning… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Practices (GCPs), appropriate Standard Operating Procedures (SOPs), Food and Drug Administration (FDA) regulations/EU Directive, and International Conference on ... is primarily a tactical study delivery role, reporting into an Associate Director (or above) responsible for Operational Study Strategy. This position may require… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of a clinical program. Relationships The Senior Medical Writer reports to a Director of Medical Writing. The Senior Medical Writer is expected to develop and ... Science, Clinical Pharmacology, Biostatistics, Clinical Operations, Regulatory Affairs, Global Safety , Data Management, and Non-clinical Development. Essential Functions Authors,… more
- Merck (West Point, PA)
- …Our Company is seeking a highly motivated candidate for the position of Director , Vaccine Drug Product Development. Vaccine Drug Product Development ... The Director will report to the Executive Director of Vaccine Drug Product Development, have...and other regulatory requirements for CMC. Strong experience in safety and environmental knowledge and site presence. + Candidate… more
- Catalent Pharma Solutions (Somerset, NJ)
- **Account Director , Biologics Drug Substance** Catalent Biologics is a fast-growing business within Catalent Pharma Solutions focused on providing innovative ... WI. This position has responsibility for establishing new biologics drug substance partnerships in the target territory. Success will...a difference. Catalent is committed to the health and safety of its employees, visitors and the customers and… more
