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  1. Director, HQ Medical, Immuno-Oncology, Life Cycle Management at BMS

    He or she will partner closely with medical colleagues in the Markets, with Clinical Research, Discovery, Regulatory, Commercial, Access, Health Outcomes and...

  2. Associate Director, Regulatory Process & Standards at Shire

    The Regulatory Process Standards Lead will further the vision for Global Regulatory Affairs (GRA) in alignment with the One Shire business model to establish...

  3. Thought Leader Liaison, Neurology - New York at Merck KGaA

    Build advocacy with KOL’s by utilizing on label, Legal and Regulatory approved materials to support the brand and commercial strategy....

  4. Thought Leader Liaison, Neurology - New York at EMD

    Build advocacy with KOL’s by utilizing on label, Legal and Regulatory approved materials to support the brand and commercial strategy....

  5. Thought Leader Liaison, Neurology - Northwest at EMD

    Build advocacy with KOL’s by utilizing on label, Legal and Regulatory approved materials to support the brand and commercial strategy....

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    1. Senior Medical Writer for Leading Biopharmaceutical Company

      Senior Medical Writer for Leading Biopharmaceutical Company·         Medical Writer·         Pennsylvania, USA·         $145,000 - $160,000An established and leading biopharmaceutical company is looking for a Senior Medical Writer for the preparation of their scientific and regulatory affairs documents. Experience with writing INDs and NDAs is a must as the medical writer will be preparing ...

    1. Senior Manager, Public Relations at PixarBio Corporation

      Coordinates Legal, Medical and Regulatory internal review process for materials developed. Potential litigation, product discontinuation and supply issues and...

    1. Quality Assurance Manager

      Due to unprecedented growth our client a generic pharmaceutical company located in New Jersey currently has approval to add to its staff a Manager of Quality Assurance.JOB SUMMARY:The Manager of Quality Assurance provides for the development and implementation of computerized and other processes that will assure that primary documentation systems encompassing records mandated to comply with ...

    1. Medical Science Liaison / Driector at Connecta Parma Recritment

      Medical Affairs and U.S. Firm working knowledge of GCP, scientific and clinical methodology, protocol design, project management and regulatory requirements for...

    1. Scientific Quality Auditor

      *Please note that this is a 6 month contract assignment. Candidates cannot start an assignment until background check and drug test is completed*Responsibilities: Under the direction of CMC Auditing supervision, the Auditor conducts routine document audits of CMC data and information included in regulatory submissions to ensure data accuracy and integrity and compliance with Standard ...

    1. IT Operational Permanent Control, Risk & Governance at Linium

      Liaise with the US Regulatory Affairs Team to identify IT procedure needs and assist with creation and maintenance and coordinate IT responses to regulatory...

    1. Director, Medical Affairs

      SUMMARY OF POSITION:  This position will be accountable for planning, developing and executing  US Medical Affairs plans and Strategy.Key Accountability·         Planning, development and implementation a Medical Affairs strategy for  products in collaboration with Management·         Identify, develop, and maintain relationships with thought leaders and foster scientific and medical input ...

    1. CA Political Director, Ecosystems at Environmental Defense Fund

      Senior Vice President, External Affairs & Communications. Extensive experience with CA state legislative and regulatory structures, and solid understanding of...

    1. REGULATORY SPECIALIST

      This position requires "in-vitro diagnostic" (IVD) experience along with FDA experience, handling pre and regular submissions to the FDA. Assist in defining US regulatory submission strategies to assure timely and successful product clearances. Beyond the U.S., interactions could be with Canadian, European, and other international regulatory authorities. Provide regulatory strategies for ...

    1. Technical Service Manager--Key Accounts at Kemin Industries, Inc.

      Ability to work in cross-functional teams to achieve customer and product objectives, including R&D, Regulatory Affairs and Operations....

    1. Clinical Trial Manager

      BioStaff Solutions is seeking a Clinical Trial Manager for a 6 -12 month renewable contract with potential to go perm.Responsible for the oversight and management of all clinical operational activities at the trial and site level for assigned clinical projects. Leads internal cross-functional teams and manages the Sponsor relationship with vendors and CROs to ensure successful execution of ...

    1. Senior Manager Regulatory Affairs - Topical Pain at Robsco Search

      8 year experience within Regulatory Affairs. Our client currently have a Category Regulatory Affairs Senior Manager vacancy within our global Pain category...

    1. Clinical Data Analyst

      Responsibilities: Plans and coordinates Ongoing Data Review (ODRM)/ Risk Base Monitoring (RBM) deliverables for multiple projects/ studies, inputs into RBM plan and specification for identified outputs Set up and generate outputs using visual tools with clinical data for ODRM/RBM variables across multiple projects/studies Communicate findings from data and to create interactive ...

    1. Executive Director, Medical Affairs at Lexicon Pharmaceuticals, Inc.

      The Executive Director, Medical Affairs is a critical executive responsible for leading the execution of medical affairs activities, managing medical affairs...

    1. REGULATORY SPECIALIST

      The Market Access Regulatory Specialist will be responsible in helping to define US regulatory submission strategies. He/She will be responsible for drafting and reviewing submission documents and interacting with other individuals within the Market Access Department as well as with regulatory bodies to assure timely and successful product clearances. Beyond the US, interactions could be ...

    1. Labeling Associate (Regulatory Affairs) at The Veritas Healthcare Solutions LLC.

      Job Title: Labeling Associate Location: South Plainfield, NJ Duration: Contract Position Summary: The Labeling Associate ensures preparation and availability

    1. SR CLINICAL TRIAL MANAGER

      I represent The Fountain Group. We are a national staffing firm and are currently seeking a SR CLINICAL TRIAL MANAGER for a prominent client of ours. This position is located in EAST HANOVER, NJ. Details for the position are as follows: Job Description:Seeking an experienced SR CLINICAL TRIAL MANAGERProvides leadership to one or more Study Management Teams (SMTs) and provides strategic ...

    1. Regulatory Affairs Labeling Associate at ResourceHunt Group

      Regulatory Affairs Labeling Associate*. Labeling and regulatory:. 1 year of labeling or regulatory experience preferred. South Plainfield, NJ.*....

    1. REGULATORY SPECIALIST

      The Market Access Regulatory Specialist will be responsible in helping to define US regulatory submission strategies. He/She will be responsible for drafting and reviewing submission documents and interacting with other individuals within the Market Access Department as well as with regulatory bodies to assure timely and successful product clearances. Beyond the US, interactions could be with ...

    1. Regulatory Operations Lead, CMC at Reckitt Benckiser Group

      RB is recruiting for Regulatory Operations Lead, CMC for our North American Regulatory Affairs team located in Parsippany, NJ....

    1. Director of Medical Science/Translational Research

      Director of Medical Science/Translational ResearchThe Director of Medical Science/Translational Research will join our evolving Medical Science/Translational Research team in Clinical Research to investigate indications (i.e. how to clinically use a molecule) and create clinical development for new molecules. The expected therapeutic areas will be immunology, dermatology, internal medicine or ...

    2. Regulatory Affairs Associate #5644AS

      Our client, a leading Orthopedic company located in Parsippany, NJ, is looking for add a Regulatory Affairs Associate for an 8 month contract position.Position will pay up to $32.31/hr. based on experience and education.Regulatory Affairs Associate Job Summary:Responsible for assisting the team with regulatory filings as necessary to market products.  This is an entry level position, ...

    3. Regulatory Affairs Specialist

      Maintains technical files for in vitro diagnostic products in compliance with the European In Vitro Diagnostics Directive 98/79/EC (IVDD). Prepares and reviews regulatory documentation to support conformance to the IVDD. Must possess good technical writing skills and have a scientific background. Knowledge and experience with development and global registration of in vitro diagnostic products ...

    4. Clinical Data Analyst

      Responsibilities:Plans and coordinates Ongoing Data Review (ODRM)/ Risk Base Monitoring (RBM) deliverables for multiple projects/ studies, inputs into RBM plan and specification for identified outputsSet up and generate outputs using visual tools with clinical data for ODRM/RBM variables across multiple projects/studiesCommunicate findings from data and to create interactive visualizations ...

    5. Clinical Data Analyst

      Responsibilities:Plans and coordinates Ongoing Data Review (ODRM)/ Risk Base Monitoring (RBM) deliverables for multiple projects/ studies, inputs into RBM plan and specification for identified outputsSet up and generate outputs using visual tools with clinical data for ODRM/RBM variables across multiple projects/studiesCommunicate findings from data and to create interactive visualizations ...

    6. Drug Safety Physician

      Vivos Professional Services is currently seeking candidates for a Pharmacovigilance Leader opportunity in East Hanover, New Jersey. Incumbent performs medical assessment and related activities for single cases, including collecting additional follow-up information as necessary, medical evaluation of quality defects, review of the line listings of single cases and preparation of investigator ...

    7. Clinical Data Analyst

      Responsibilities: Plans and coordinates Ongoing Data Review (ODRM)/ Risk Base Monitoring (RBM) deliverables for multiple projects/ studies, inputs into RBM plan and specification for identified outputs Set up and generate outputs using visual tools with clinical data for ODRM/RBM variables across multiple projects/studies Communicate findings from data and to create interactive ...

    8. Drug Safety Physician

      Vivos Professional Services is currently seeking candidates for a Pharmacovigilance Leader opportunity in East Hanover, New Jersey. Incumbent performs medical assessment and related activities for single cases, including collecting additional follow-up information as necessary, medical evaluation of quality defects, review of the line listings of single cases and preparation of investigator ...

    9. REGULATORY AFFAIRS ASSOC I

      Our client is a world leader and innovator in the Pharmaceutical industry. They offer continuous growth, learning, and development for their employees. Since 1980 APR Consulting, Inc. has provided professional recruiting and contingent workforce solutions to a diverse mix of clients, industries, and skill sets nationwide. Job Title: Regulatory Affairs Associate I. Job Details: The RA ...

    10. Clinical Data Analyst

      Responsibilities:Plans and coordinates Ongoing Data Review (ODRM)/ Risk Base Monitoring (RBM) deliverables for multiple projects/ studies, inputs into RBM plan and specification for identified outputsSet up and generate outputs using visual tools with clinical data for ODRM/RBM variables across multiple projects/studiesCommunicate findings from data and to create interactive visualizations ...

      1. Thought Leader Liaison, Neurology - Northwest at Merck KGaA

        Build advocacy with KOL’s by utilizing on label, Legal and Regulatory approved materials to support the brand and commercial strategy....

      2. Executive Director, Disease Lead USMA - Multiple Myeloma at Celgene

        Interface effectively with all Medical Affairs at all levels (global, regional, affiliate) and other departments, including Commercial, Clinical Research and...

      3. Director, Field U.S. Health Economics and Outcomes Research (HEOR) at Celgene

        Medical Affairs, Legal & Regulatory, U.S. Celgene is a global biopharmaceutical company leading the way in medical innovation to help patients live longer,...

      4. Director, Global Marketing, Multiple Myeloma at Celgene

        Partners with Global Medical Affairs lead on publication planning, IIT, KOL and Med Education strategies. Celgene is a global biopharmaceutical company leading...

      5. Director, Clinical Studies at PixarBio Corporation

        Coordinate with Regulatory Affairs to determine and meet FDA guidelines and submission requirements. Leading society’s mandate for non-opiate and non-addictive...