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Medical Writer III, Regulatory Affairs

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Medical Writer III, Regulatory Affairs

  • Location:

    Tukwila, Washington

  • Sector:

    Pharmaceutical

  • Job type:

    Direct Hire

  • Contact email:

    Ashley Edwards

  • Job ref:

    9946

  • Published:

    15 days ago

  • Expiry date:

    2021-04-11

Medical Writer III, Regulatory Affairs

Tukwila, WA

Job Id: 9946

 

Are you looking to make a career change to a professional and stable company? This exciting opportunity offers a competitive salary plus an excellent benefits package including medical, dental and vision insurance as well as PTO. Does this position match your future career goals? Then this opportunity could be the right fit for you.

 

 

RESPONSIBILITIES:

  • Synthesizing data and scientific advice from different disciplines well written documents
  • Preparing, reviewing, and editing regulatory documents for Health Authority submissions
  • Identifying and resolving problems regarding medical/regulatory writing issues
  • Providing technical guidance to make sure that data presented in documents follow applicable regulatory guidelines, as well as goals of the submission
  • Ensure that all work is complete and of high quality prior to team distribution
  • Coordinating production and distribution of documents
  • Aiding in study design, GCP-compliance, and effective responses to Health Authorities
  • Managing various tasks at the same time and prioritize a competing workload
  • Coordinating with team members regarding the scope of work, timeline, project goals, and technical information throughout the project to make sure appropriate goals and timelines are met
  • Providing strategic and project planning for medical writing activities.
  • Maintaining business and clinical knowledge of the treatment landscape for therapeutic areas relevant to company pipeline
  • Participating in conferences, training, and initiatives regarding company interests and therapeutic areas
  • Other roles may be allocated according to department needs

 

QUALIFICATIONS:

  • MD, PharmD, PhD or other doctoral-level degree preferred and minimum 2 years of related pharma/biotech experience or Bachelor’s degree with 6 to 8 years of related pharma/biotech experience
  • Preferred medical writing experience with document types applicable to early phase drug development, with experience in management of complex medical writing projects
  • Proven experience with project planning tools, systems, and processes
  • Proven experience with team leadership
  • Fluent in written and spoken English
  • Ability to thrive in a fast-paced and entrepreneurial environment
  • Flexibility to adapt to changing needs in real time

 

BENEFITS:

  • Medical Insurance
  • Dental Insurance
  • Vision Insurance
  • 401K
  • Direct Hire

 


Ask for: Ashley

ashley@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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