Senior Medical WriterCK 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.