Contract Medical Writer

**Job Title**: Contract Medical Writer
**Work Location**: Remote
**Country**: Europe time Zone
**Duration**: 12 months
**Rate**: €70 to €90 depending on experience
**Your main duties as a Contract Medical Writer will include**:

- Working on NDA/BLA/MAA submissions, this includes writing and editing all clinical regulatory documents which includes CSRs, IBs, Protocols, and Summaries
- Authoring of Module 2 clinical documents, including Briefing Books, and Paediatric Plans
- Providing oversight for outsourced writing deliverables, and identifying, deploying and managing resources

**Additional duties will include**:

- Overseeing/Mentoring for all document types and offering leadership and basic accountability, strategic assistance, and planning support at the product level for clinical regulatory documents
- Ensuring that clinical documents include the proper content and context from a regulatory medical writing perspective
- Participating in the preparation/revision of document templates, development of process, and preparation/revision of SOPs and guidance documents

**Your Background**:

- PhD/PharmD in life sciences (or other related field) with a minimum of 5 years of experience, or
- Master’s degree in life sciences (or other related field) with a minimum 7 years of experience.

**Language requirements**:
English (verbal and written) at professional working level
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It is essential that applicants already hold entitlement to work in Europe. Please quote job reference 108 443 in all correspondence.
INDENTT