Summary:
A leading global provider of advanced analytics, technology solutions and clinical research services to the life science industry is currently looking for a remote Medical Writer II. You will prepare assigned documents in accordance with SOP's and customer requirements per agreed timeline. This is an advanced regulatory position working with complex clinical study reports and protocols. Maintain knowledge of current medical writing and regulatory skills including GCP and the developments and advances in clinical drug development. Are you motivated and passionate about the life science industry? If yes, please reach out to learn more.
Responsibilities:'
- Take leading role in preparing assigned documents in accordance with company's SOP's including confirming the scope of the task, confirming templates and specifications, negotiating and adhering to timelines, and organizing document reviews
- Manage day to day workload including identifying project needs, tracking timelines and implementing customer requests
- Keeping manager/senior staff abreast of progress on tasks and any potential problems with project work.
- Understanding of budgets and project finance principals
- Work with complex CSR's and protocols
- Provide guidance and training to junior colleagues
- Propose revisions to SOP's
- Lead customer meetings independently and communicating directly with the customer
Qualifications:
- Bachelor's Degree in life sciences related discipline or related field is required
- Master's Degree and/or PhD. in life sciences related discipline or related field is preferred
- Typically requires at least 3 years of prior relevant experience and related competency levels, including acting as lead writer for clinical study reports and clinical study protocols
- Significant experience as a lead writer in preparing CSRs and protocols
- In depth knowledge of drug development, medical writing, and associated regulations.
- Good understanding of statistical principles and of medical terminology across a range of therapeutic areas.
- Ability to identify deficiencies, errors, and inconsistencies in a protocol or report.
- Experience acting as lead writer for clinical study reports and clinical study protocols
Benefits:
- Flex Friday's
- Work from home
- PTO
- HSA/FSA
If you are interested in the Medical Writer II position, then please don't wait to apply.
