Medical Writer I-Cds

Covance Chicago , IL 60602

Posted 2 months ago

Job Overview:

The Meical Writer I-CDS will be responsible for independently preparing lower complexity protocols and CSRs including interpretation of clinical data and statistical results as appropriate.

  • Works with more experienced colleagues in the development of higher complexity protocols and CSRs and other clinical documents as needed.

  • Independently prepares and reviews patient safety narratives.

  • Provides support and project management of narrative projects.

  • Prepares and/or oversees compilation of CSR appendices.

  • Prepares documents in accordance with Covance/Client Standard Operating Procedures and specifications as applicable, and relevant ICH and regulatory/industry guidelines.

  • Independently reviews Statistical Analysis Plan (SAP) and Tables, Listings, and Figures (TLFs) for assigned studies to ensure appropriate data presentation for CSR purposes. Provides feedback on SAP and TLFs to project team as needed.

  • Incorporates internal and/or external review comments on clinical documents.

  • Communicates with internal/external clients as needed to facilitate achievement of project goals.

  • Participates in meetings with internal and external clients, with guidance and support from colleagues.

  • Leads meetings as appropriate.

  • Responsible for project coordination and adherence to project timelines and budget, as appropriate.

  • Represents department in inter-department working groups.

  • Provides training and guidance to Associate Medical Writers and other staff as appropriate.

  • Complies with Covance internal processes and procedures.

  • Performs other duties as assigned by Management.

Education/Qualifications:

Minimum of first degree in life sciences (or equivalent); advanced degree (e.g., PhD or Masters) preferred

Experience:

  • 1-year medical writing experience or 2 years professionally-related experience

  • Excellent command of written and spoken English

  • Good written and verbal communication skills

  • In-depth knowledge of MS Word

  • Good organizational and time management ability

  • Excellent interpersonal skills

  • Scientific or Clinical research experience desirable

  • Good scientific writing skills

  • Understanding of medical, pharmacokinetic and statistical principles

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Medical Writer I-Cds

Covance