Regulatory Medical Writing Operations Lead
4 weeks ago
**𝗘𝘅𝗰𝗹𝘂𝘀𝗶𝘃𝗲 6 𝗠𝗼𝗻𝘁𝗵 𝗖𝗼𝗻𝘁𝗿𝗮𝗰𝘁 (20 hours) – 𝗠edical Writing Operations Lead – Remote, 𝐔𝐊 **
Are you an experienced Medical Writing Operations Lead passionate about pioneering therapies in the biotech industry? Join our innovative client, a pioneer in developing revolutionary CAR-T cell therapies for cancer treatment
𝐖𝐡𝐲 𝐡𝐞𝐫𝐞?
- You'll have the opportunity to contribute to releasing groundbreaking therapies for critically ill patients.
- Be inspired by the collective expertise and shared commitment to transforming cancer treatment.
- Work in a dynamic setting that celebrates diversity, experiences, and collaborative efforts.
- Excellent opportunities for professional growth and development alongside experienced professionals and cutting-edge projects.
As a Medical Writing Operations Lead, you will be primarily responsible for all aspects related to document quality review, including data verification, editorial oversight, adherence to company style and regulatory standards, as well as submission ready formatting for routine and non-routine clinical and non-clinical regulatory documents.
𝐊𝐞𝐲 𝐑𝐞𝐬𝐩𝐨𝐧𝐬𝐢𝐛𝐢𝐥𝐢𝐭𝐢𝐞𝐬:
• Provide editorial support and guidance during authoring of regulatory documents, ensuring adherence to company style and industry standards, as well as clarity, consistency, and proper usage of language and grammar.
• Support document authors with submission ready formatting for Word and PDF regulatory documents according to company guidelines and industry standards using company tools and templates, in collaboration with Regulatory Operations.
𝐀 𝐛𝐢𝐭 𝐨𝐟 𝐰𝐡𝐚𝐭 𝐲𝐨𝐮’𝐥𝐥 𝐧𝐞𝐞𝐝:
• Quality review and editorial oversight of regulatory documents, and/or a related field in the pharmaceutical or biotechnology industry
• Working with electronic document management systems (EDMS) in a regulatory environment
• Successfully interacting with cross functional team members
If you're interested and would like to find out more, reach out on LinkedIn or send your CV to lewis.ray@skillsalliance.com
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