- Merck & Co. (Rahway, NJ)
- … or Associate Vice President, Therapeutic Area Lead.Develops worldwide product regulatory strategy to optimize label and obtain shortest time to approval ... The Director , Regulatory Affairs Liaison is responsible for:Developing regulatory strategy for their assigned products, in order to optimize label… more
- Merck & Co. (Durham, NC)
- …the new HPV vaccine drug substance manufacturing facility. As a direct report to the Director of Operations, the Associate Director will be accountable for ... Capital project management experience Risk Management experience Experience supporting regulatory inspections- Change Execution Management / Strategy Realization… 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 ... team at Millsboro. This is a key role in driving our Digital Manufacturing strategy where value is ultimately delivered for the Manufacturing Division. This role is… more
- Merck & Co. (North Wales, PA)
- Job DescriptionThis position drives scientific planning, strategy and execution of Phase 1-4 clinical studies.-Under the direction of the Program Lead, you will ... trial team.Collaborates with the Medical Writer on clinical/scientific and regulatory documents.Partners with Study Manager on study deliverables.Participates in the… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one of the most diverse and collaborative groups within the ... organization. From health-care-provider interactions and developing and implementing regulatory strategies with the FDA to providing medical education and collecting… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …agreed quality standards and timelines and that quality of data is suitable for regulatory submission. The Associate Director will have routine interaction ... regulations/EU Directive, and International Conference on Harmonization (ICH) guidelines. The Associate Director is accountable for operational planning and… more
- Insmed Incorporated (Bridgewater, NJ)
- …Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewAssociate Director , Tech Ops (Process Chemistry) will have responsibility for the ... manufacturing, process characterization and validation, and manufacturing CMC development strategy . Remote (only in corp. office for purposeful meetings)ResponsibilitiesResponsibilities… more
- Eisai, Inc (Nutley, NJ)
- …a difference. If this is your profile, we want to hear from you. The Associate Director , Omnichannel Marketing and Media position reports to the Senior ... Director , Omnichannel Marketing (HCP and Patient). The associate director will also partner closely with key internal partners to deliver omnichannel and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and patient case management Ensure that patient support programs data strategy aligns with organizational goals and regulatory requirements, working ... focusing on optimizing patient care and support. Relationships Reports to the Director of PSP Analytics and Ops Excellence. Key internal relationships include… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the development of study protocol (design, sample size, statistical analysis strategy ); Review CRF; Write SAP; Manage statistical analysis outputs with programming ... Statistical deliverables. Contribute, with limited supervision, to documents submitted to Regulatory or Pricing Authorities. May participate as subject matter expert… more
- Legend Biotech USA, Inc. (Piscataway, NJ)
- …immunotherapy in the treatment of multiple myeloma. Legend Biotech is seeking an Associate Director Immuno-Oncology as part of the Research and Development team ... cell-based therapies. We are seeking an experienced and dynamic Associate Director to lead our in vivo...show the value of collaboration and teamwork, and provide strategy , expertise, resources, and guidance in a cross-functional environment.… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- … regulatory agencies. Supervise designated personnel. Relationships Report to the Director / Associate Director /Lead Regulatory Scientist/Sr. Manager ... The Position Manage and oversee all assigned projects/products/processes. Assist the Director / Associate Director in assuring Novo Nordisk compliance… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …ensuring consistency and harmonization of the implementation of the CMR training strategy Ensuring CMR employees receive training on regulatory compliance, ... About the Department The Clinical Development, Medical and Regulatory (CMR) department at Novo Nordisk is one...and harmonization of the implementation of the CMR training strategy . Serve as the CMR Training representative; Liaise with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …the FDA and other health authorities globallyCreates a forward-looking Diagnostic development strategy while keeping abreast of regulatory and policy updates in ... disorders. Summary The primary responsibilities of this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support… more
- Aequor (Newbury Park, CA)
- …requires resourcefulness and critical thinking skills.) Job Title: Sr. Associate - Records Information Management & Systems (RIMS)Job DescriptionKey responsibilities ... Support the implementation of Veeva Vault, IDMP, EU CTR, and other regulatory initiatives. Work with stakeholders to gather requirements and develop solutions.… more
- Eisai, Inc (Nutley, NJ)
- …this is your profile, we want to hear from you.Accountable for the strategy , prioritization and planning for IT systems and projects. Partner with business leaders, ... and systems. Establish functional IT governance to define an overall vision, strategy and priorities to address unmet business needs. Lead the definition of… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …equal opportunity employer including veterans and people with disabilities. Summary The Associate Director , External Data Management, is accountable for the ... providers for clinical trials, companion diagnostics trials, clinical development, and regulatory submissions. This position may propose strategies for external data… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …multiple complex and competing priorities simultaneously. Proven project management and strategy skills. Is experienced in leading complex initiatives of high dollar ... Demonstrates strong knowledge of the industry, vendor base, and regulatory issues for respective categories. Leads the development of sourcing… more
- Insmed Incorporated (Bridgewater, NJ)
- …in Biopharma™, Best Workplaces in New York™, and Best Workplaces for Millennials™ lists.OverviewThe Associate Director , HCP Marketing will be a key member of the ... our culture. This position will report to the Senior Director , HCP and Payer Lead. This position does not...necessarily be limited to, the following:Develop and implement the strategy for the brand's personal and non-personal promotional efforts… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas centered around rare diseases and immune disorders. SUMMARYThe Associate Director , Pharmacoepidemiology position provides epidemiologic, methodological, ... study protocols.This position independently manages relationships with internal (CSPV, Regulatory , Clinical, Medical Affairs, HEOR and other stakeholders to ensure… more
