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Search Results for Clinical Affairs Manager
- Medical Affairs Specialist
- AngioDynamics, Inc. - Albany/Poughkeepsie, New York
- Pharmaceutical
- Job Title: Medical Affairs SpecialistProfession: Biotechnology/Pharmaceuticals -> Clinical Development ProfessionalsPosition Summary: Establish, oversee and manage functions within the global Medical Affairs department with high degree of independence. As necessary, establish supporting databases, intranet sites and other mediums for the purpose of managing all Medical Affairs professional (physician) requests for information. This position will also be responsible for arranging all logistics of the NanoKnife Case Observation Program and handling other world-wide Medical and Clinical (see more)
- Sr. Manager/Associate Director, Regulatory Affairs
- Noven Pharmaceuticals, Inc - Westchester, New York
- Pharmaceutical
- OVERALL RESPONSIBILITIES Responsible for developing and implementing clinical/nonclinical and CMC regulatory strategies for assigned products across a range of therapeutic classes, which may include both development and marketed products. ESSENTIAL DUTIES Develop and drive regulatory strategies independently for projects of moderate complexity or with support of more senior regulatory personnel for projects of high complexity. Assess regulatory options and communicate to regulatory management and project team. Interacts with FDA and other regulatory agencies throughout the development (see more)
- Medical Affairs Specialist
- AngioDynamics, Inc. - Albany/Poughkeepsie, New York
- Healthcare / Nursing
- Job Title: Medical Affairs Specialist Profession: Biotechnology/Pharmaceuticals -> Clinical Development Professionals Position Summary: --Establish, oversee and manage functions within the global Medical Affairs department with high degree of independence.-- As necessary, establish supporting databases, intranet sites and other mediums for the purpose of managing all Medical Affairs professional (physician) requests for information.-- This position will also be responsible for arranging all logistics of the NanoKnife Case Observation Program and handling other world-wide Medical and (see more)
- Regulatory Affairs Manager
- Toshiba Corporation - Westchester, New York
- Pharmaceutical
- Job Title: Regulatory Affairs ManagerProfession: Biotechnology/Pharmaceuticals -> Clinical Development ProfessionalsToshiba America Medical Systems, Inc., a world leader in diagnostic imaging, is in search of qualified candidates to fill our open positions. Toshiba offers a competitive salary and benefits package, we support a diverse workplace and are an equal opportunity employer. We invite you to join TAMS and become part of our Toshiba family. In this position, you will be responsible for pre-market activities to include new product planning and remedial actions on released (see more)
- Regulatory Affairs Administrator
- Aerotek - Long Island, New York
- Other / Miscellaneous
- Regulatory Affairs Administrator Job Description: Duration: 2 years The Administrator, CDU-CRA is responsible for: - Assemble documentation for new Regulatory filings; file amendments/update files as necessary: - 510(k) / European Technical Files / Worldwide registrations - Communicate with manufacturers to obtain necessary information required for filings - Track renewal requirements and file renewals as necessary - Track status of registrations and answer questions - Generate and provide Certificates of Foreign Goods upon request - Service as liaison with distributors, consultants, and (see more)
- Regulatory Affairs Administrator
- Aerotek - Long Island, New York
- Healthcare / Nursing
- Regulatory Affairs Administrator Job Description: Duration: 2 years The Administrator, CDU-CRA is responsible for: - Assemble documentation for new Regulatory filings; file amendments/update files as necessary: - 510(k) / European Technical Files / Worldwide registrations - Communicate with manufacturers to obtain necessary information required for filings - Track renewal requirements and file renewals as necessary - Track status of registrations and answer questions - Generate and provide Certificates of Foreign Goods upon request - Service as liaison with distributors, (see more)
- Dir, Clin/PC Reg Affairs
- Siemens USA - Westchester, New York
- Pharmaceutical
- Job Title: Dir, Clin/PC Reg AffairsProfession: Biotechnology/Pharmaceuticals -> Clinical Development ProfessionalsDir, Clin/PC Reg AffairsCompany Siemens Healthcare Diagnostics Inc.Division SMSD - DiagnosticsFunctional Area QA - Quality Assurance/Regulatory Affairs/Regulatory ComplianceLocation NY - TarrytownReq ID 103876Job Type RegularJob Time Full-TimeExperience Level Senior LevelRequired Education Bachelors Degree or equivalent experienceRequired Travel 30%Company DescriptionSiemens is an Equal Opportunity Employer encouraging diversity in the workplace. Job (see more)
- Director Regulatory Affairs Strategy Pharma Products
- Nice-Pak Products, Inc. - Westchester, New York
- Pharmaceutical
- Job Title: Director Regulatory Affairs Strategy Pharma ProductsProfession: Biotechnology/Pharmaceuticals -> Clinical Development ProfessionalsJob Title: Director Regulatory Affairs Strategy Pharma ProductsState/ Province: New YorkCity: OrangeburgDescription: Essential Function:Reporting to the Sr. Director of Regulatory Affairs, this position is responsible for determining the optimum pathways to gain regulatory approval to market new and improved Pharma products developed for PDII. This position is responsible to ensure that the pathways are both compliant meet the established (see more)
- Technical Writer Regulatory Affairs
- Nice-Pak Products, Inc. - Westchester, New York
- Information Tech / Computer
- Job Title: Technical Writer Regulatory AffairsProfession: Computer Engineering and Information Technology -> Technical Writing/DocumentationJob Title: Technical Writer Regulatory AffairsState/ Province: New YorkCity: OrangeburgDescription: Essential Function:The Technical Writer is responsible for writing and editing regulatory submissions for our Pharma Products both domestically and internationally. This position will write the CMC sections for regulatory submissions for NDAs, INDs, ANDAs, PMAs , 510Ks and international submissions. The Technical Writer is responsible for (see more)
- Technical Writer Regulatory Affairs
- Nice-Pak Products, Inc. - Westchester, New York
- Publishing / Journalism
- Job Title: Technical Writer Regulatory Affairs Profession: Computer Engineering and Information Technology -> Technical Writing/Documentation -- Job Title: Technical Writer Regulatory Affairs State/ Province: New York City: Orangeburg Description: Essential Function: -- The Technical Writer is responsible for writing and editing regulatory submissions for our Pharma Products both domestically and internationally. This position will write the CMC sections for regulatory submissions for NDA's, IND's, ANDA's, PMA's , 510K's and international submissions. The Technical Writer is responsible for (see more)
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