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Job ID 216506BR Position Title Expert Medical Writer Division Global Drug Development Business Unit GDO GDD Country Switzerland Work Location Basel Company/Legal Entity Novartis Pharma AG Functional Area Research & Development Job Type Full Time Employment Type Regular Job Description To write, edit and manage the production of high quality clinical documentation for submission to regulatory authorities in support of marketing applications. To provide authoritative document-related expertise to DE and other line units.
1. Act as a member of clinical trial teams and submission teams and autonomously write/edit clinical study reports, CTD summary and overview documents, and other regulatory documents.
2. Provide authoritative guidance to other line units and within DE with respect to regulatory submission documents and other document-related issues.
3. As requested by DE management, act as lead writer on submissions and co-ordinate production of summary documents by medical writing team in collaboration with clinical team.
4. Write/edit other strategic documents, as required, in collaboration with project teams and where necessary, with support from Senior Expert Medical Writers or DE leadership team members.
5. Participate in planning of analysis and data presentation to be used in clinical programs, individual study reports or summary documents.
6. Act as project medical writer for complex submission programs in clinical development.
7. Contribute to development of document templates and processes both within DE and more widely.
8. Act as mentor to other medical writers. Minimum requirements Education:
Minimum university life science degree or equivalent. Higher degree desirable.
Excellent written and spoken English.
1. At least 4 years medical writing experience or other relevant pharmaceutical industry experience combined with scientific and regulatory knowledge, plus strong knowledge of medical writing processes.
2. Excellent medical writing skills.
3. Expert data interpretation and presentation skills.
4. Good understanding of statistics.
5. Expert knowledge of regulatory requirements and clinical development.
6. Excellent communication skills.
7. Good leadership skills within cross-functional teams.
8. Good influencing and negotiating skills.
9. Experience of coordinating writing activities for regulatory submissions.
10. Good presentation skills.
11. Ability to mentor other medical writers.
12. Experience of process improvement initiatives