Medical Writing

Job Description :

• Setting, discussing and meeting expectations of the document during kick off and subsequent meetings
• Lead the authoring / editing of clinical documents, as mentioned above.
• Ensure adherence to established processes, timelines, regulatory guidelines and applicable standards, styles, guidelines
• Perform quality review of the clinical documents within established timelines with adherence to applicable guidelines, templates, and processes
• Ability to effectively and proactively communicate with internal and external stakeholders, including authors and key opinion leaders as appropriate (including problem-solving and resolution of issues)
• Keep abreast of project status, clinical operating plans and ongoing / new studies as well as scientific literature within assigned project
• Maintain and develop current knowledge of regulatory guidelines, technological advances and industry standards
• Training and mentoring of the new recruits / existing medical writers
• Oversee live projects assigned to the new medical writers and guide them as required

As required, take on functional role and responsibilities of the role of Documentation Lead –

Skills Required

Medical Transcription, meeting