- Daiichi Sankyo, Inc. (Bernards, NJ)
- …This position serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational leadership on product ... labeling in collaboration with Global Regulatory Leads (GRLs). This position may serve as an...labeling issues for late stage projects. This position manages multiple assigned projects of increased complexity including post marketing… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- … regulatory experienceSuccessful track record in preparation, management of review and approval of NDA/MAA/BLA with FDA and EMACompetencies:Advanced knowledge of ... rare diseases and immune disorders.Job Summary: This position manages multiple biological developmental projects with supervision, including working with contract… more
- Merck & Co. (Rahway, NJ)
- …This includes the ability to:Apply strong knowledge of clinical research regulatory requirements (eg, GCP and ICH)Manage multiple competing priorities ... trial team.Collaborates with the Medical Writer on clinical/scientific and regulatory documents.Partners with Study Manager on study deliverables.Participates in the… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders. Summary: The Associate Director will lead the execution and lifecycle management of Global Medical ... and ensuring adherence to timelines.Program Leadership: Lead and manage multiple research programs, demonstrating expertise in both strategy formulation and… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study problems. ResponsibilitiesProtocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, ... medium complexity studies including study design, protocol development, CRF review , SAP development, analysis files development, statistical analysis accuracy… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …study problems. Responsibilities Protocol Development, Case Report Form (CRF; review ), Statistical Analysis Plan (SAP), Statistical Analysis, Results Interpretation, ... for complex studies including study design, protocol development, CRF review , SAP development, analysis files development, statistical analysis accuracy validation,… more
- Merck & Co. (Rahway, NJ)
- … Regulatory , Operations, Non-clinical, Clinical, and other functional areasExperience with regulatory submissions including writing / review of regulatory ... formulation, manufacturing process, and primary packaging to enable phase appropriate regulatory filings for large molecule sterile products. -These sterile products… more
- Fidelity TalentSource LLC (New York, NY)
- …investigation includes but is not limited to a criminal, civil litigations and regulatory review , employment, education, and credit review (role dependent). ... Job Description:RoleAs a Senior Associate , you will help to provide H&W clients...skillsYou have a strong aptitude to balance and prioritize multiple projects in a fast-paced work environmentYou have an… more
- Fidelity TalentSource LLC (Jersey City, NJ)
- …investigation includes but is not limited to a criminal, civil litigations and regulatory review , employment, education, and credit review (role dependent). ... experience at financial services institutions, eg, asset managers, banks, regulatory agencies (required)Experience with brokerage products and services, brokerage… more
- Fidelity TalentSource LLC (Jersey City, NJ)
- …investigation includes but is not limited to a criminal, civil litigations and regulatory review , employment, education, and credit review (role dependent). ... Cloud EngineersExperience with configuring and deploying resilient infrastructure in multiple regions and multiple availability zonesWork multi-functionally with… more
- Fidelity TalentSource LLC (Jersey City, NJ)
- …investigation includes but is not limited to a criminal, civil litigations and regulatory review , employment, education, and credit review (role dependent). ... Python, R, SQL, Java, Linux.Ability to optimally connect with multiple partners, including fundamental and quantitative researchers, technology partners and… more
- Fidelity TalentSource LLC (Jersey City, NJ)
- …investigation includes but is not limited to a criminal, civil litigations and regulatory review , employment, education, and credit review (role dependent). ... improve our productivity; guides junior team members on technologyCollaborate with multiple stakeholders/large cross functional teams as part of work deliveryFollows… more
- Fidelity TalentSource LLC (Jersey City, NJ)
- …investigation includes but is not limited to a criminal, civil litigations and regulatory review , employment, education, and credit review (role dependent). ... queries and analytical tools and methodologies including SQLEffectively manages multiple initiatives and responsibilities within prescribed timelinesAbility to engage… more
- Fidelity TalentSource LLC (Nanuet, NY)
- …investigation includes but is not limited to a criminal, civil litigations and regulatory review , employment, education, and credit review (role dependent). ... and in an Investor Center.Obtain Licenses: Become a FINRA (Financial Industry Regulatory Authority) Registered Representative by studying for and obtaining your SIE,… more
- Publicis Groupe (New York, NY)
- …| Facebook: www.facebook.com/digitashealth | Twitter: www.twitter.com/digitas_health **Job Description** The Associate , Regulatory Review works closely with ... create various components of each submission for a Manager, Regulatory Review or Senior Associate ,...+ Produce and assemble submission packages + Comfortably handle multiple projects and work with multiple teams… more
- Publicis Groupe (New York, NY)
- …Facebook: www.facebook.com/digitashealth | Twitter: www.twitter.com/digitas_health **Job Description** The Senior Associate , Regulatory Review must follow ... by our pharmaceutical company clients when submitting marketing materials for regulatory review . This includes preparing completed editorial content to… more
- Publicis Groupe (New York, NY)
- …www.facebook.com/digitashealth | Twitter: www.twitter.com/digitas_health **Job Description** The Sr Manager, Regulatory Review is responsible for managing a ... the protocol established by our pharmaceutical company clients for regulatory review . The Senior Manager plays a...to meet all deadlines. **DUTIES & RESPONSIBILITIES:** + Manage multiple direct reports at the Associate , Senior… more
- Haleon (Warren, NJ)
- …projects. **What will your individual contribution at Haleon be?** The expectation for the Regulatory Affairs Associate role will be as follows: + Work within ... goal. Right now, we're looking for Co-Ops student in Regulatory Affairs to join us to do career defining...in the market by using strategies and coordinating with multiple departments to achieve a product fit for the… more
- Gilead Sciences, Inc. (Parsippany, NJ)
- … activities, and representing Regulatory to cross-functional teams for multiple products. + Experience chairing/leading promotional review committees or ... relevant experience. + For external candidates, 4+ years' experience in regulatory review of promotions for prescription drugs or other biologic products. +… more
- Mizuho Corporate Bank (New York, NY)
- …control enhancements. Summary: You will be primarily responsible for testing and validating multiple regulatory reports to ensure that they are prepared in ... Quality Assurance Unit is responsible for enhancing the integrity of the bank regulatory reporting processes, reporting data quality as well as the overall control… more
