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 ofDocumentation Lead

• Lead PDRD deliverables for project and act as first point of contact for any information that is required for content/document preparation
• Ensure alignment and content re-use across documents for a product
• Onboard lead document writers on document content alignment and timelines.
• Provide required source documents incl. information pertaining to study documentation, relevant project contacts (authors, reviewers), developmental strategy
• Actively participate in Regulatory Affairs Functional or other cross functional team meetings
• Review content of document prior to finalization to ensure high quality prior to initiation of author review or Expert Team Review