- Daiichi Sankyo, Inc. (Bernards, NJ)
- …apprehend safety context through the product life cycle.Understanding of Safety Risk Management internal and external environment, including applicable ... program or multiple early-stage programs, in order to proactively perform safety surveillance and risk management in partnership with Product Safety Lead(s),… more
- Genmab (Plainsboro, NJ)
- …authentic is essential to fulfilling our purpose.Reporting to the VP, Head of Global Drug Safety & PV, the Senior Director , Global Drug Safety & ... throughout their lifecycle. This includes leading all major pre- and post-marketing safety related deliverables including signal, benefit- risk evaluation, and … more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …of Clinical, medical, Regulatory (CMR) Business Operations, the Associate Director (AD) is responsible for structuring facilitating and monitoring external-facing ... agreements including, but not limited to, Master Service Agreements (MSAs), Safety Data Exchange Agreements (SDEAs) and Statement of Works (SOWs). The AD will be… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …areas centered around rare diseases and immune disorders. SummaryThis position supports safety monitoring and risk management activities, provides insights on ... Expert - Signal Evaluation: Assists manager in assessing new signals. Safety Expert - Risk Mitigation & Communication: Communicates any safety concerns to… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …internal and external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key internal ... Safety Update Reports (DSURs), periodic SUSAR reports, Periodic Safety Update Reports (PSURs) and Risk Management...reports, Periodic Safety Update Reports (PSURs) and Risk Management Plans (RMPs) according to implementation plans or… more
- Merck & Co. (Durham, NC)
- …on all the programs described above. Reports to the site's Executive Director of Engineering, Maintenance and Site Services. GENERAL PROFILE Provides leadership and ... for the daily support of all production equipment to ensure area safety , compliance, production and financial goals are metResponsible for spare parts … more
- Merck & Co. (Rahway, NJ)
- …enable and accelerate process and product development and manufacturing and ensure safety and quality of our products. The successful candidate will be accountable ... for proactive resourcing planning, risk assessment strategies and will focus on talent development and partnering to build an integrated culture of innovation across… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the development of clinical sections of study-level documents (eg, protocol, amendments) of safety data to mitigate risk to trial participants for the assigned ... Director , Clinical Development Join a Legacy of Innovation...assessment of protocol deviationsDiscusses medical eligibility questions and answers safety questions (dose modifications, discontinuations, and management of adverse… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …the development of clinical sections of study-level documents (eg, protocol, amendments)- Reviews safety data to mitigate risk to trial participants for the ... 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. (Bernards, NJ)
- …to the development of clinical sections of study-level documents (eg, protocol, amendments)Reviews safety data to mitigate risk to trial participants for the ... areas centered around rare diseases and immune disorders. SummaryThe Senior Director sits within Global Oncology Clinical Development, an organization dedicated to… more
