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  1. Regulatory Affairs Specialist

    Regulatory Affairs Specialist – Warren, NJ Contract Position An Associate Director position is available within our clients Regulatory Affairs Advertising and Promotion Dept.   Responsibilities will include, but are not limited to, the following: • Manage regulatory aspects of Post-Marketing regulatory submissions and communications with the Food and Drug Administration (FDA) Office of Prescription Drug Promotion (OPDP) [formerly the Division of Drug Marketing, Advertising and Communications ...

  2. Sr. Regulatory Affairs Associate

     Our client, a pharmaceutical company, is seeking a Sr. Regulatory Affairs Associate till the end of the year.  The pay rate is up to $74 an hour plus benefits. The Sr. Regulatory Affairs Associate will be responsible for: • Advise stakeholders of submission completion. • Find information and potential answers to challenging areas related to assigned projects in the interest of keeping the project streamlined and moving forward. • Assist in the preparation of regulatory documents. • Compile ...

  3. Director, Medical Science

    Director, Medical Science, Summit NJ area SUMMARY The Director of Medical Science (MS) is responsible for providing input into the Global Project Teams in planning, designing, developing, executing and interpreting clinical studies, including but not limited to those carried out in North America (NA) the global development program. The responsibilities include, but are not limited to writing or reviewing study synopsis and protocols, medical monitoring of clinical studies, input into clinical ...

  4. Pharmacovigilance Officer

    Pharmacovigilance Officer Position Purpose: Pharmacovigilance Officer is responsible for instituting and maintaining the key aspects of PV regulation in the US territory, in line with Pharmacovigilance Group processes and standards. The role involves collecting, monitoring, submission to FDA, and documenting of adverse reactions concerning all medical products, ensuring compliance with the company’s global/local procedures, national and international regulations/guidelines. Additional ...

  5. Research Coordinator (contract to perm)

    Amazing opportunity with a pharmaceutical company in Princeton, NJ. The company is seeking a Program Operations Executive (POE) to join their team. This is a contract (3 - 6 month) opportunity with the possibility of becoming an FTE. The POE will establish and maintain effective program services, conduct data and document collection, perform information analysis, and ensure regular and comprehensive communication with external partners such as site physicians and staff. The POE will also provide ...

  6. Research Coordinator (contract to perm)

    Amazing opportunity with a pharmaceutical company in Princeton, NJ. The company is seeking a Program Operations Executive (POE) to join their team. This is a contract (3 - 6 month) opportunity with the possibility of becoming an FTE. The POE will establish and maintain effective program services, conduct data and document collection, perform information analysis, and ensure regular and comprehensive communication with external partners such as site physicians and staff. The POE will also provide ...

  7. Director, Global Quality Audits

    Bristol-Myers Squibb is a global biopharmaceutical company whose mission is to discover, develop and deliver innovative medicines that help patients prevail over serious diseases. One shared journey is moving us forward at Bristol-Myers Squibb. Around the world, we are passionate about making an impact on the lives of patients with serious disease. Empowered to apply our individual talents and ideas so that we can learn and grow together. And driven to make a difference, from innovative research to ...

  8. Medical Science Director - Oncology

    Medical Science Director - Oncology  Require a Medical Degree (MD) with strong scientific background and medical practice experience, a fellowship or equivalent  Experience in a pharmaceutical or biotech company, especially in early stage, exploratory clinical development of drugs and biologics. At least 5 years of work experience in performing early development clinical activities (e.g. writing protocols and executing studies, formulating clinical development strategy and plans, providing ...

  9. BIOSTATS SPECIALIST

    Our client, a large pharmaceutical company, is currently seeking a BIOSTATS SPECIALIST.This job will have the following responsibilities:Work under the direction of Medical Affairs Statistics Disease Lead.Actively provide statistical support to the Medical Affairs Department.Provide statistical support for publications, presentations, posters at medical meetings and any other requests not covered in the clinical study report. This includes data mining, meta-analysis, and support for data-driven ...

  10. Associate Director Regulatory Affairs (Post Marketing, Oncology)

    Our client is an established oncology focused pharma company located in Princeton NJ. This company has a strong oncology pipeline, offers a collaborative and supportive culture and there are clearly defined opportunities to contribute and grow with the company. Our client has a promising pipeline of oncology products, including a Phase III drug that will be going to the FDA later this year. Because of growth, there is a newly created Regulatory Affairs Associate Director (Promotional) opportunity. ...

  11. Regulatory Affairs Associate

    Our client, a pharmaceutical company, is seeking a Regulatory Affairs Associate for 6+ month.  The compensation is up to $42 an hour plus benefits. Regulatory Affairs Intelligence • Proactively monitor and identify US regulatory intelligence sources (e.g. FDA, HHS, PHRMA, US Government, publications,  competitor website, and industry publications). • Disseminate intelligence in a timely manner, to relevant groups within  (e.g. Legal, Marketing, Sales) or Headquarters. • Fulfill regulatory ...

  12. Project Physician – Job#: 14-00982

    Our client in Titusville, New Jersey is looking for a Project Physician.This is a long term consulting position.If interested, Please apply to this ad Position: Project Physician Location: Titusville, New Jersey Job#: 14-00982 Description The Project Physician is a responsible member of a clinical team (Compound Development Team, CDT)) and reports to the CDT Leader. The PP will be dedicated to working with the team to manage the execution of a Phase 3 Efficacy and Safety Study of an anti ...

  13. Sr. Director/VP, Regulatory Affairs

      Roles and Responsibilities: -Assembling documents for IND, 505b(2) and ANDA filing using eCTD format -Working with regulatory software in compiling eCTD submissions -Working with FDA in obtaining feedback on Q1/Q2 confirmations, clinical protocols, other regulatory requirements -Providing sound response strategy for addressing FDA deficiencies -Providing regulatory strategy on all development programs -Coordinating and compiling response to FDA deficiencies -Project management of select ...