Job Overview:
Medical Writer II
Remote: US
The Medical Writer II will prepare protocols and CSRs, including interpretation of clinical data and statistical results as appropriate. Work under guidance from colleagues to assist development of protocols, CSRs and other clinical documents on complex studies and programs. Prepare and review patient safety narratives. Leads project management and coordination of narrative projects. Oversee and coordinate other writers on CSR appendices compilation. Prepare documents in accordance with Labcorp Drug Development/Client Standard Operating Procedures and specifications as applicable, and relevant ICH and regulatory/industry guidelines.
Additional responsibilities:
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
Prioritize and forward plan workload to a high standard; to advise Management of problems promptly
Participate independently in internal and external client meetings. Lead meetings as appropriate
Responsible for project coordination and adherence to project timelines and budget
Identify ways to improve the efficiency and quality of work processes
Mentor Associate Medical Writers and Medical Writer I, as appropriate
Provide peer review and input on deliverables prepared by colleagues, as appropriate based on experience
Provide training to Medical Writers and other staff as appropriate
Represent department in audits and inter-department working groups
Comply with Labcorp Drug Development 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:
Minimum Required:
Typically minimum 3 years medical writing experience including 1 year as medical writing project lead
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
Knowledge of ICH guidelines applicable to medical writing
Good understanding of medical/scientific terminology and experience in data analysis and interpretation
MPA position: This would be to help in the Office Associate role for Medical Records on the units. They sort/file...
Apply For This JobJob Description Position Title: Supervisor Sanitation Position Type: Regular – Full-Time Position Location: Othello Requisition ID: 12206 About McCain: McCain...
Apply For This JobThis is a remote position. Back-End Developer (Entry Level) – US/Canada, Full-Time, Salary $60K $70K Minimum 1 year of work...
Apply For This JobWe are looking for a Data Entry Clerk to join our team. Candidate must be reliable as you will be...
Apply For This JobWe are seeking an Overnight Boarding Attendant to join our team! You will be responsible for the overall care and...
Apply For This Jobbr{display:none;}.css-58vpdc ul > li{margin-left:0;}.css-58vpdc li{padding:0;}]]> Need a an office personal assistant to help with general office work, setup, errands and...
Apply For This Job