The Scientific Team at Russell Tobin and Associates is hiring a Senior Medical Writer for our client’s Medical and Regulatory Writing Department based out of Trenton, NJ!
This is a 1 year contract opportunity with potential for extension or conversion.
- Write and coordinate the development of protocols, CSRs or other clinical documents including those of a more complex nature
- Provide support in development of submission level documents under guidance of senior staff
- Oversees management and coordination of complex narrative projects
- Produces scientific papers, abstracts and/or posters, and presentations.
- Responsible for all medical writing aspects of project development and coordination, adherence to timelines and budget
- To prioritize and plan workload to a high standard. Effectively manage multiple assignments in parallel
- Prepare documents in accordance with Client Standard Operating Procedures and specifications as applicable, and relevant ICH and regulatory/industry guidelines
- 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.
- Act as medical writing contact for major clients and partners
- Keep up to date with developments in Medical Writing
- In consultation with more experienced staff, show initiative and ability to deal with complex project situations
- Inform management of medical writing problems promptly and propose solutions
- Provide advice on Medical Writing issues to project team members (internal and external) and help to resolve problems
- Contribute to Medical Writing initiatives to develop and improve processes
- Mentor and provide guidance and training to other medical writing staff
- Provide peer review and input on deliverables prepared by colleagues
- Provides scientific leadership and support to colleagues in the data management and reporting team
- Provide support for Business Development opportunities such as time and cost estimates, attendance at client bid defense meetings, industry conferences
- Review SOPs and associated documents
- Represent department in audits and inter-department working groups
- Comply with internal processes and procedures
- Performs other duties as assigned by Management
- Minimum of first degree in life sciences (or equivalent); advanced degree (e.g., PhD or Masters) preferred
- Typically minimum 4 years medical writing experience including 2 years as medical writing project lead
- Excellent command of written and spoken English
- Excellent written and verbal communication skills
- In-depth knowledge of MS Word
- Excellent organizational and time management ability
- Detailed knowledge of ICH guidelines applicable to medical writing
- Good understanding of medical/scientific terminology and experience in data analysis and interpretation
- 1 year contract opportunity
- W2 position
- Must be eligible to work in the United States. Unable to provide visa sponsorship now or in the future.
- Russell Tobin & Associates offers benefit options to our employees after 60 days.
Interested? APPLY NOW! #CB