Labcorp Medical Writer I, Early Phase in Annapolis, Maryland
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
Minimum of first degree in life sciences (or equivalent); advanced degree (e.g., PhD or Masters) preferred.
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