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Medical Writer

  • Location: Lawrenceville, Mercer, New Jersey
  • Job Type:Contract

Posted 21 days ago

  • Expiry Date: 02 August 2021

​​Job Description:

Expected Areas of Competence:

  • Ability tdevelop a range of written materials such as detailed instructions for high level principles-based documents

  • Demonstrated ability twrite complex processes in a logical order using simplified language, creation of visual process flow diagrams, and information mapping techniques

  • Strong GCP and ICH knowledge, including local/regional guidelines which are applicable tclinical research and the regulatory landscape

  • Ability teffectively manage projects, escalate issues as necessary and meet key milestones

  • Ability tlead and facilitate writing team meetings, that contribute tattaining team goals and resolving complex issues

  • Ability tevaluate utility of documents and assemble content tensure clarity for users (including those whare not native English speakers)

  • Collaboratively work with Regulatory and Clinical colleagues tensure any process changes resulting from the issuance of new or revised GCP/ICH Guidelines, regulations, and other guidelines applicable tclinical research are documented appropriately, in an appropriate format

  • Work with autonomy and is able table tnegotiate and influence others without direct authority

Qualifications:

  • Bachelors degree with a minimum of 5-10 years experience in global drug development

  • Demonstrated knowledge of Good Clinical Practice (GCP) ICH

  • Guidelines and applicable FDA regulations

Project Management:

  • Demonstrated ability tsuccessfully manage competing deadlines and balance priorities while meeting or exceeding expectations

  • Demonstrated ability tmaintain a high level of productivity, accountability and energy

  • Demonstrated success in managing project team effectiveness, through facilitation and presentation skills ta globally diverse audience

Document Development and Review:

  • High level of writing competency, specifically in the appropriate use of grammar, syntax and organization of ideas on paper

  • Provides close attention tdetail and excellent follow up

  • Ability ttake very detailed information and distill it down tfocus on key messages

  • Flexible thinker with a growth mindset

  • Proactively use judgment and creativity tmanage risk and uncertainty, and tanticipate the need for and implement contingency plans

  • Affinity towards fully utilizing technology

About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting connects people with amazing opportunities

ASK Consulting is an equal opportunity employer. We celebrate diversity and are committed to creating an inclusive environment for all associates.