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Technical Writer/Editor

  • Location: Tarrytown, Westchester, New York, 10591
  • Job Type:Contract

Posted about 1 month ago

Position: Technical Writer/Editor
Location: Tarrytown, NY 10591
Term: 3 months
 
Day-to-Day Responsibilities:
  • Prepares, edits, and finalizes protocols, investigator brochures, synopses, regulatory documents and related clinical documents, such as abstracts, posters, presentations, and manuscripts.
  • Participates in scientific communication planning, including development of strategic medical communication plans.
  • Partners with the study biostatistician to engage early with the study team including participation in the review of mock and/or blinded tables, figures, and listings (TFLs), and narrative planning for
    relevant documents.
  • Works closely with the study team to ensure that results and messages in clinical documents accurately reflect the data in TFLs and other information sources.
  • Schedules and conducts document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes.
  • Collaborates to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents.
  • Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed.
  • Works closely with the study team to reach consensus on timelines for deliverables.
  • Completes documents according to agreed-upon timelines and follows up with the study team as needed to meet internal and external timeline commitments, and to ensure SOP and regulatory compliance.
  • Understands the functions and roles within the study team and aligns with them in delivery of documents to meet project-related goals and to meet external results disclosure obligations.
  • Manages all aspects of outsourced or internal CSR production and ensures project delivery.
  • Ensures that medical writing deliverables conform to International Conference on Harmonization (ICH) and other relevant regulatory guidelines.
 
Is this a good fit? (Requirements):
  • PhD or MD with scientific/medical publication record in peer-reviewed journals.
  • Experience or knowledge in areas of hematology, blood cancers (i.e. Multiple Myeloma), renal disease (nephrology)

Candidates will be responsible for following the client's COVID-19 protocols. Please refer to your MATRIX representative for specifics.

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