The Expert Medical Writer writes, edits and manages the production of high quality clinical documentation for submission to regulatory authorities in support of marketing applications. Provides authoritative document-related expertise to Document Excellence (DE) and other line units.
1. Act as a member of clinical trial teams, project teams, and submission teams and autonomously write/edit clinical study reports, investigator s brochures, clinical evaluation reports (including all components), , and other medical device submission 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 and co-ordinate production of documents by medical writing team in collaboration with clinical, project and/or submission teams.
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 for individual study reports or summary documents.
6. Act as project medical writer for complex submission programs.
7. Contribute to development of document templates and processes both within DE and more widely.
8. Act as mentor to other medical writers.
The Novartis Group of Companies are Equal Opportunity Employers and take pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.
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
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