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Regulatory Writing Manager

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Regulatory Writing Manager

  • Location:

    Cincinnati, Ohio

  • Sector:

    Manufacturing

  • Job type:

    Direct Hire

  • Contact email:

    Jayme Faulkner

  • Job ref:

    12184

  • Published:

    10 days ago

  • Expiry date:

    2021-09-05

Regulatory Writing Manager

Cincinnati, OH

Job Id: 12184

 

Are you looking to make a career change to work in an innovative work environment? This opportunity offers a competitive salary plus an excellent benefits package including medical, dental and much more. Does this position match your future career goals? Then this opportunity could be the right fit for you.


RESPONSIBILITIES:

  • Responsible for departmental hiring, training, management, and evaluation of Medical Writers and other support personnel
  • Medical Writing group in the development of IND, NDA, and MAA components across a variety of therapeutic areas;
  • Primary writer and/or project manager for key documents or projects;
  • Interpret and apply clinical considerations and regulatory strategies to document development working with Medical and Regulatory experts
  • Develop timelines for writing projects working with Sponsors and internal departments
  • Determine and present scope of work for bid proposals.


QUALIFICATIONS:

  • Master’s degree or PhD/ 5 years of medical writing experience Preferred
  • Bachelor’s degree with at least 7 years medical writing experience Required
  • Supervisor experience required
  • Proficient computer, project management and attention to detail skills Required
  • Excellent communication skills (both written and oral), analytical and problem-solving skills
  • Knowledge of writing US and/or EU regulatory documents Preferred
  • Scientific background Preferred


BENEFITS:

  • Medical
  • Dental
  • Direct Hire
  • Travel: 15-20%

 

Ask for: Jayme Faulkner

jayme@ajuliaexecutivesearch.com

Ajulia Executive Search is a New Jersey based Executive Search Firm specializing in retained searches in multiple sectors, including Manufacturing, Finance, IT, Legal, and Pharmaceutical. We have a nationwide client base and offer services in temporary and direct hire placements.


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