Neurodiversity Advisors Inc. Jobs

Mobile Neurodiversity Advisors Logo

Job Information

Labcorp Medical Writer I, Early Phase in Lansing, Michigan

Job Overview:

Medical Writer I, Early Phase

Remote in the US or Canada

Medical Writers in the Early Clinical Medical Writing (MW) group would typically work on clinical documents for studies in the early phases of clinical development (e.g., Phase I studies focused on pharmacokinetics and pharmacodynamics).

  • Prepares low complexity protocols and CSRs, including interpretation of clinical data and statistical results as appropriate

  • Work under guidance from colleagues to assist development of high complexity protocols, CSRs and other clinical documents on complex studies and programs

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

  • Participate in review of Statistical Analysis Plan (SAP) and Tables, Figures and Listings (TFLs) to ensure appropriate data presentation for CSR purposes. Provide feedback on SAP and TFLs to project team as needed.

  • Incorporates internal and/or external review comments on clinical documentation

  • Participate independently in internal and external client meetings. Lead meetings as appropriate

  • Responsible for project coordination and adherence to project timelines and budget

  • Comply with Labcorp internal processes and procedures

Education/Qualifications:

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

Experience:

Minimum requirements:

  • 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

DirectEmployers