Description
I have an excellent opportunity for an experienced Regulatory Medical Writer (Clincal Study reports/Clinical Summary Documents/Protocols/IB's/Submissions) for a 12 month contract. The regulatory writer must have a proven track record for a pharma writing regulatory documents such as clinical study reports, clinical summary documents, protocols and experience with submissions.Key Skills for the Regulatory Medical Writer:
- Clinical Study Reports (CSR)
- Clinical Summary Documents
- Protocols
- IB's (investigatory brochures)
- Submissions (FDA or NDA)
- ICH guidelines
- Getting involved with strategic plans,
- demonstrate leadership capabilities,
- vendor oversight
- working with cross functional teams
The role is to be homebased/based out of PA (2 days offsite/3 days onsite). This pharma is growing rapidly and there is a strong possibility that this contract will be renewed/offered a permanent opportunity. I am looking for someone who has previously led a submission, or alternatively made a significant contribution
I have been impressed with clients product line and growth plans and I feel this is one of the best contracts out there at the moment. If you are interested, please get an up to date CV across and I will be in touch.
To find out more about Real please visit www.realstaffing.com