- Aequor (Washington, DC)
- …MS, Pharm D, MD, PhD or equivalent preferred Minimum 3 years in Regulatory Affairs Established regulatory experience Effective collaboration Familiarity and ... manage interactions and communications with trade associations and health authorities on regulatory policy matters. Lead proactive advocacy efforts for client's… more
- Aequor (San Diego, CA)
- US Regulatory Affairs Lead SCOPE OF RESPONSIBILITIES: He/She will be responsible for representing regulatory function to approve promotional material ... preferred Regulatory Certification (RAC) preferred Minimum 5 years in Regulatory Affairs , including leadership roles Experience: Experience in promotional… more
- Novo Nordisk Inc. (Plainsboro, NJ)
- …designated personnel. Relationships Report to the Director/Associate Director/ Lead Regulatory Scientist/Sr. Manager Regulatory Affairs . Develop and ... positive rapport and working relationships with other personnel in Regulatory Affairs , CMR, and other local and...meetings (pre-IND, EOP 2, pre-NDA, pre-BLA) for review by Project Leaders Write Regulatory documents translating team… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …centered around rare diseases and immune disorders. Summary The Manager, Regulatory Affairs - Regulatory Project Management (RPM) provides planning and ... regulatory activities. The Manager RPM is responsible for supporting the global regulatory lead (GRL), US regulatory lead (USRL) and global … more
- Aequor (Newbury Park, CA)
- …in SharePoint, has working experience with the Six Sigma method and project management experience. The type of qualities/characteristics the hiring manager is ... Support the implementation of Veeva Vault, IDMP, EU CTR, and other regulatory initiatives. Work with stakeholders to gather requirements and develop solutions.… more
- Merck & Co. (Rahway, NJ)
- Job DescriptionAs a Project Manager within the Strategy Realization Office (SRO) function of GMSA at our company, the successful applicant will play a critical role ... in leading major global initiatives aimed at enhancing Medical Affairs practices. The SRO is a recognized internal management consulting team within Medical… more
- Novo Nordisk Inc. (Chicago, IL)
- …knowledge and knowledge of the region to enhance territory management of field teams Lead project teams to manage and support various projects such as digital ... About the Department The Clinical, Medical and Regulatory (CMR) department at Novo Nordisk is one...This position may report into the Field Director, Medical Affairs (or in smaller TA's directly into the TA… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …preferred. Experience Qualifications:4 or More Years of proven experience in a regional regulatory lead role7 or More Years of relevant pharmaceutical experience ... regulatory strategy for assigned development projects. Represents Daiichi Sankyo's regulatory group in internal and external development project meetings.… more
- Eisai, Inc (Nutley, NJ)
- …the digital competencies and strategy within Scientific Communications and Medical Affairs . Lead digital initiatives ensuring successful evaluation, execution and ... solutions and drive best practices within Scientific Communications and Medical Affairs .Drive oversight, project management and delivery of digital… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Years pharmaceutical industry experience required4 or More Years of direct regulatory affairs experience, including US labeling experience requiredExperience ... serves as the GRA labeling expert to the Global Regulatory Team (GRT) and independently provides strategic and operational...may serve as an ad hoc member of Global Project Team (GPT) to address labeling issues for late… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …disclosure for collection, retention, testing and retesting of samples Project Team Participation: Provide device-specific regulatory insight/guidance during ... (WG) cross-functional meetings. Serve as member of the Joint Project Team (JPT) with the Diagnostic (Dx) Partner to...device company HA meetings as appropriateIn collaboration with therapeutic Regulatory leads and CDx lead develop key… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …Gather business requirements for reporting and analyticsEngage with key stakeholders, including Regulatory Affairs teams and cross-functional project team ... Regulatory Data Manager will be a key member of the Global Regulatory Affairs (GRA) Process Excellence function, responsible for driving data governance,… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …including veterans and people with disabilities.SummaryThis position leads the Global Regulatory Affairs (GRA) Global Labeling function, combining knowledge of ... 10 or More Years pharmaceutical industry experience required- 10 or More Years regulatory affairs experience, including direct experience with CCDS, US and and… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Liasions to ensure successful implementation of CDx and data collection- Supports Regulatory affairs in providing content and providing review of documents ... this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support...are likely to benefit from our therapeutics.Responsibilities:- Leads CDx project teams for the diagnostic, in full alignment with… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …creation of developmental and regulatory strategy in collaboration with Regulatory Affairs ; Drafts clinical development plans, protocol profiles and sections ... indication, ie, multiple multinational phase II/III clinical trials; Reviews regulatory documents from cross functional, holistic perspective; Represents clinical… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …areas such as biostatistics, data management, clinical operations, pharmacovigilance, regulatory affairs , etc. Qualifications: Successful candidates will be ... Provide strategic leadership for all statistical programming activity related to study, project and submission. Manage CRO to ensure high quality compound and… more
- DivIHN Integration Inc (Green Oaks, IL)
- …contact one of our Talent Specialists Meghna at ### Rashi at ### Title: Regulatory Affairs Specialist Location: Abbott Park, IL Duration: 7 Months Description ... role As an individual contributor, the function of a Regulatory Affairs Specialist is to provide support...maintains work schedule. Establishes priorities of work assignments. May lead a departmental project team. Establishes and… more
- DivIHN Integration Inc (North Chicago, IL)
- …one of our Talent Specialists Meghna at ### Rashi at ### Title: Specialist Regulatory Affairs Duration: 7 Months Location: Abbott Park, IL/ Columbu, OH ... head of a unit/department. Accountability / Scope: As the professional in the Regulatory Affairs function, the individual will assist teams in the registration… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- …and study protocols.This position independently manages relationships with internal (CSPV, Regulatory , Clinical, Medical Affairs , HEOR and other stakeholders to ... tactical decisions utilizing input from upper management that impacts more than one project team at a time. This position will also support planning for epidemiology… more
- Daiichi Sankyo, Inc. (Basking Ridge, NJ)
- … Liasions to ensure successful implementation of CDx and data collection- Supports Regulatory affairs in providing content and providing review of documents ... this position are to guide the strategy and to lead the implementation of companion diagnostics (CDx) in support...are likely to benefit from our therapeutics.Responsibilities- Leads CDx project teams for the diagnostic, in full alignment with… more
