A global healthcare leader, Novartis has one of the most exciting product pipelines in the industry today. A pipeline of innovative medicines brought to life by diverse, talented and performance driven people. All of which makes them one of the most rewarding employers in their field.
Post: Senior Medical Writer 2
Job Description:
To write, edit and/or manage the production of high quality clinical documentation for submission to regulatory authorities in support of marketing applications.
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.
Candidate Profile:
Minimum university life science degree or equivalent. Excellent written and spoken English.
1.At least 3 years medical writing experience.
2.Good knowledge of statistics and data interpretation and presentation skills.
3.Very good knowledge of clinical documentation.
4.Good knowledge of regulatory requirements.
5.Good knowledge of drug development.
Additional Information:
Job ID: 124244BR
Experience: Min. 3 Years
Industry Type: Pharma/Biotech/Clinical Research
End Date: 30th Aug, 2013
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