Job Description
1.Write/edit regulatory documents (e.g. CSRs, DSURs, RMPs, contribute to CTD summaries).
2.Participate in planning of analysis and data presentation to be used in study reports or summary documents.
3.Act as a member of clinical trial teams following protocol finalization
4.Act as documentation consultant in clinical trial teams to ensure compliance of documentation to internal company standards and external regulatory guidelines.
5.Act as project medical writer for various programs in clinical development and ensure medical writing resource allocation to studies within these programs.
6.Contribute to process improvement initiatives
7.Supervise outsourcing to external medical writers.
8.Follow and track clinical trial milestones and resource requirements for assigned projects
9.Training and mentoring of associates as required.
Apply now
1.Write/edit regulatory documents (e.g. CSRs, DSURs, RMPs, contribute to CTD summaries).
2.Participate in planning of analysis and data presentation to be used in study reports or summary documents.
3.Act as a member of clinical trial teams following protocol finalization
4.Act as documentation consultant in clinical trial teams to ensure compliance of documentation to internal company standards and external regulatory guidelines.
5.Act as project medical writer for various programs in clinical development and ensure medical writing resource allocation to studies within these programs.
6.Contribute to process improvement initiatives
7.Supervise outsourcing to external medical writers.
8.Follow and track clinical trial milestones and resource requirements for assigned projects
9.Training and mentoring of associates as required.
Apply now
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