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regulatory affairs in Allentown

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  1. Associate Director of Clinical Affairs at Cure SMA

    Experience with clinical drug development process and regulatory issues required. The Associate Director of Clinical Affairs will oversee the day-to-day...

  2. VP/SVP Global Regulatory Affairs at Celldex Therapeutics, Inc.

    VP/SVP Global Regulatory Affairs*. The regulatory lead will oversee both the strategic and operational aspects of the regulatory objectives, including...

  3. Associate Director Clinical at Abbott Laboratories

    Management experience in other clinical operations and/or regulatory affairs positions desirable. Collaborates with functional management to ensure an...

  4. Associate Director, Medical Affairs, Levant Job at MSD

    Regulatory Compliance Knowledge. Provides strategic medical and scientific input to Business Units, Regulatory Affairs, Market Access......

  5. Medical Science Liaison/Sr. MSL Women's Cancer I/O- NYC at AstraZeneca

    Adhere to internal standard processes and comply with regulatory and compliance requirements. The incumbent engages in scientific information exchanges with...

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    1. Integrated System Support Manager

      Requisition ID:  WD74936  Integrated System Support ManagerThe role will be Business System Owner (BSO) for the regulated Healthcare Information Factory (HIF) environment used by R&D. The users are primarily in Real-World Evidence and Vaccines but there are also users in UK Pharma, VEO and US Medical Affairs.  HIF is R&D’s repository for observational, or real-world, patient-level data. The ...

    1. Director, Medical Affairs at SynteractHCR, Inc.

      10+ years Medical Affairs experience or equivalent combination of education and experience. Collaborates with the Global Vice President, Medical and Regulatory...

    1. Sr. Specialist, Quality Assurance

      SR. SPECIALIST, QUALITY ASSURANCE - 6mo. Temp - Perm rolePOSITION SUMMARY: Responsible for documentation review, verification, and analysis and trending of: analytical data, OOS Investigations, GMP Investigations, Deviations, CAPAs, and complaints. Participates in the quality review of APIs batch records, drug product batch records and medical device DHRs.Responsible for executing the quality ...

    1. Plant Manager I at Clearwater Paper

      Participate in regulatory audits. Represent Clearwater in community affairs. Ensure that all regulatory requirements are met....

    1. Pharmacovigilance Coordinator

      ESSENTIAL FUNCTIONS:1. Collect and accurately document adverse event reports.2. Triage incoming adverse event information for completeness, consistency and seriousness which includes medical evaluation and assessment.3. Forward adverse event reports, which have been received for book-in to the Argus Safety System.4. Complete processing of adverse events in the Argus Safety System ensuring ...

    1. Agilent RA/QA QMS Auditor at Agilent

      Collaborate with Agilent’s medical device regulatory experts to ensure consistent regulatory interpretations, strategies and programs....

    1. Clinical Trial Manager

      The Clinical Trial Manager is responsible for the oversight and management of all clinical operational activities at the trial and site level for assigned clinical projects. The leads internal cross-functional teams and manages the Sponsor relationship with vendors and CROs to ensure successful execution of clinical trials.ESSENTIAL FUNCTIONS:• Develops and coordinates clinical trial and ...

    1. Director of Strategic Innovation at Becton Dickinson & Company

      Ensures compliance with local BD quality and regulatory policies, procedures, and practices through appropriate communication, training, and education of sound...

    1. Nurse Manager 1

      Employment Opportunity: The PA Department of Military and Veterans Affairs has one Nurse Manager 1 opening at Southeastern Veterans Center in Spring City, which is in Chester County. Applications will only be accepted between April 18 and April 29, 2016. Nature of Work: An employee in this job plans, organizes, and directs the administrative and clinical functions of the Nursing ...

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      No Telecommute

    1. International Sales Region Manager at SalesForce4Hire LLC

      Production, scheduling, purchasing, shipping, engineering, document control, and regulatory affairs. Manage registration and regulatory issues to requests and...

    1. Clinical Trial Manager

      Vivos Professional Services is currently seeking candidates for a Clinical Trial Manager position. The Clinical Trial Manager (CTM) is responsible for the oversight and management of all clinical operational activities at the trial and site level for assigned clinical projects. The CTM leads internal cross-functional teams and manages the Sponsor relationship with vendors and CROs to ensure ...

    1. Associate Director Regulatory Advertising & Promotions at Dennis Partners

      Provide regulatory leadership and guidance to the marketing team during the development, review and approval of product labeling and advertising materials...

    1. Director Regulatory Affairs

      Globally renowned Pharmaceutical Manufacturing Company has an immediate opening for a Director Regulatory Affairs to join their dynamic team in Bethlehem, PA. Company offers extremely generous compensation, bonus, and executive benefits package. Work environment is very pleasant and collaborative.Purpose of Job:Operational responsibilities: Providing leadership in all aspects of regulatory ...

    1. Director Regulatory Advertising & Promotions at Dennis Partners

      Provide regulatory leadership and guidance to the marketing team during the development, review and approval of product labeling and advertising materials...

    1. Associate Director Regulatory CMC at Dennis Partners

      Partner with Regulatory, Quality, Research, Manufacturing, Nonclinical and Clinical teams Assist during regulatory agency inspections Participate in regulatory...

    1. Vice President Regulatory Affairs (Full-Time Contract) at Dennis Partners

      With two marketed products, they are looking to bring a Vice President of Regulatory Affairs to lead the company’s global regulatory strategy and execution from...

    1. Vice President Regulatory CMC at Dennis Partners

      Minimum 12-15 years regulatory affairs experience Minimum of a Masters in a scientific discipline required, Ph.D....

      1. Director of Clinical Package Development at Quality Search

        Logistics, quality assurance, formulation/process development, and regulatory affairs groups to provide input into the packaging....

      2. Medical Science Liaison/Sr. MSL Women's Cancer I/O - Northern CA/Reno, NV at AstraZeneca

        Adhere to internal standard processes and comply with regulatory and compliance requirements. The incumbent engages in scientific information exchanges with...

      3. Director, Clinical Development - Hematology/Oncology (Palo Alto, CA or Philadelphia, PA) at Jazz Pharmaceuticals

        Develop regulatory strategy in response to regulatory guidelines and competitive intelligence in conjuction with project team members, regulatory affairs and...

      4. Associate Director, Medical and Scientific Writing, Regulatory Affairs (Palo Alto, CA or Philadelphia, PA) at Jazz Pharmaceuticals

        Experience with a variety of regulatory and clinical documents. The Associate Director, Medical and Scientific Writing, Regulatory Affairs is responsible for...

      5. Senior Regulatory Affairs Specialist at Cynosure, Inc.

        Provide the regulatory reviews of customer complaints and define the regulatory reportability. Member of the Regulatory team that insures regulatory approvals...