- Merck & Co. (Rahway, NJ)
- …Biologics and Biopharmaceutics, have 8-10 direct reports composed of experienced, senior and associate biopharmaceutic scientists.- The successful candidate will ... Regulatory , Operations, Non-clinical, Clinical, and other functional areasExperience with regulatory submissions including writing / review of regulatory … more
- Merck & Co. (Rahway, NJ)
- …of Biologics and Biopharmaceutics, have 10-15 direct reports composed of experienced, senior and associate scientists.- The successful candidate will effectively ... Regulatory , Operations, Non-clinical, Clinical, and other functional areasExperience with regulatory submissions including writing / review of regulatory … more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …research areas centered around rare diseases and immune disorders.Summary The Associate Director, RACMC Portfolio Products, will be responsible for regulatory ... for working on cross-functional teams, developing and executing post-approval Regulatory CMC strategies, reviewing CMC information and data, authoring CMC… 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 ... working with contract manufacturing organizations CMO. This position serves as the Regulatory Affairs (RA) CMC project representative to the CMC sub team and… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …and associated mitigation plans to management and other internal stakeholders Perform regulatory review of all clinical and nonclinical documents for ... multiple functional areas. Relationships You will report to the Senior Director - Global Regulatory Portfolio Lead. Essential Functions Serve as a member of… more
- Fidelity TalentSource LLC (New York, NY)
- Job Description:RoleAs a Senior Associate , you will help to provide H&W clients a different perspective by offering comprehensive solutions. These services can ... investigation includes but is not limited to a criminal, civil litigations and regulatory review , employment, education, and credit review (role dependent).… more
- Daiichi Sankyo, Inc. (Bernards, NJ)
- …complexity in design and geographic scope). Prepares clinical section of regulatory document. Collaborates as team member with AROs/CROs. Drafts development plans, ... Leads dose-escalation meetings; Performs quality assessment with Delivery Lead eg review Tables/Listings/Graphs before database lock and quality check of data; Works… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …safety surveillance sub-function within the US East Coast Development Hub comprised of Senior Global Safety Leads, Global Safety Leads and Senior Global Safety ... to internal and external stakeholders. Relationships This position will report to Senior Director Safety Surveillance, US East Coast Development Hub. Key internal… 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). ... partners, including fundamental and quantitative researchers, technology partners and senior managementIntelligently apply sophisticated analytics and quantitative concepts to… 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). ... our services within Fidelity Brokerage Operations & Technology (FBOT)? The RoleAs Senior Manager, Asset Services, you will blend brokerage expertise with the… 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). ... Job Description:RoleFidelity Internal Information Senior Compliance Advisor, FDAS Compliance The Role As...a culture of ethical conduct and commitment to compliance, regulatory and legal obligations. In this role on the… 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). ... for your team and help them executeDevelop close partnerships with senior business leaders, sales and relationship managers at FidelityMaintain deep knowledge… 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). ... assets. The Expectations for this RoleAdvise new product, business and senior leadership on operational risks and risk mitigation strategies. Support business… 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). ... our team reshape the future of finance. As a senior level engineer you will be an integral part...offsite with maximizing time together in person to meet associate and business needs. Currently, most hybrid roles require… more
- Publicis Groupe (New York, NY)
- …| Facebook: www.facebook.com/digitashealth | Twitter: www.twitter.com/digitas_health **Job Description** The Senior Associate , Regulatory Review ... 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)
- …effort required to create various components of each submission for a Manager, Regulatory Review or Senior Associate , Regulatory Review + Ensure ... | Facebook: www.facebook.com/digitashealth | Twitter: www.twitter.com/digitas_health **Job Description** The Associate , Regulatory Review works closely with… more
- J&J Family of Companies (Skillman, NJ)
- Senior Associate , Regulatory ...as well as existing products. + Have responsibility for review and approval of labeling and promotional material and ... Affairs - 2407025090W **Description** Kenvue is currently recruiting for: Senior Associate , Regulatory Affairs, Dietary Supplements This position reports to… more
- Publicis Groupe (New York, NY)
- …(or group of clients) follow the protocol established by our pharmaceutical company clients for regulatory review . The Senior Manager plays a key role in ... and solving potential issues across their account(s). Additionally the Senior Manager, Regulatory Review must...& RESPONSIBILITIES:** + Manage multiple direct reports at the Associate , Senior Associate , and Manager… more
- Publicis Groupe (New York, NY)
- …with the stability and experience of a global leader. **Job Description** The Senior Associate , Regulatory Promotional Operations must follow the protocol ... by our pharmaceutical company clients when submitting marketing materials for regulatory review . This includes preparing completed editorial content to… more
- Grant Thornton LLP (New York, NY)
- As a Regulatory Compliance and Operational Risk Senior Associate , you will get the opportunity to grow and contribute to our clients' business needs by ... to provide comprehensive compliance optimization strategies, to help clients remediate regulatory gaps, streamline operations and limit risk exposure. From day one,… more
