Senior Medical Writer

CK Group have a fantastic opportunity for a Senior Medical Writer (Regulatory) to join a pharmaceutical company, on a contract basis initially for 12 months.

Where:

Europe remote, ideally Germany, UK.

The Role:

The Senior Medical Writer (Regulatory) will:

• Writes and/or edits clinical regulatory documents (all document types).
• Provides oversight for outsourced writing deliverables, and identifies, deploys and manages resources.
• Prepares or reviews and maintains document timelines.
• Oversees/Mentors for all document types and offers leadership and basic accountability, strategic assistance, and planning support at the product level for clinical regulatory documents.
• Ensures that clinical documents include the proper content and context (from a regulatory medical writing perspective) and clear and consistent medical/scientific messaging, are accurate and complete, and adhere to applicable regulatory guidelines and departmental and editorial standards.
• Aids medical writing (and other) staff on the organization and presentation of information within documents, as well as the design and format of data displays.
• Ensures quality of documents and participates in meetings at the document team and clinical sub- team levels.
• May participate in the preparation/revision of document templates, development of process, and preparation/revision of SOPs and guidance documents.
• Uses various tools, business systems, and repositories.

Requirements:

• Right to work in the relevant country is essential.
• PhD educated ideally with significant experience in Regulatory Medical Writing roles.
• Experience writing all types of Regulatory documents which include CSRs, IBs, Protocols, Summaries.
• Excellent communication skills.

Apply:

Right to work in the relevant country is essential. Please quote job reference 105043 in all correspondence.