Contract Medical Writer - 12 months

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 in all correspondence.