Contract Medical Writer

il y a 1 mois

BrusselHoofdstad, Belgique CK Group Temps plein

**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
Apply
It is essential that applicants already hold entitlement to work in Europe. Please quote job reference 108 443 in all correspondence.
INDENTT

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