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: Regulatory Medical Writing-Safety Lead
Job Description:
1. Manage quality, timeliness, efficiency and high scientific standards for written and electronically published safety documents (ASRs, RMPs and PSURs) produced by the Regulatory Writing (RW) group for global teams, across geographical boundaries.
2. Act as lead for innovation projects and initiatives concerned with safety documents
3. Participate with leadership team in priority setting, workload distribution and resource planning to ensure adequate assignment of writing resource to safety documents
4. Contribute to the development of the global regulatory writing function through interactions within the leadership team.
5. Maintain document templates, documentation related processes and strategies related to safety documents.
6. Act as Local Legal Manager in Hyderabad and as Appraisal Coordinator/Development Coordinator for a group of associates (development/training plans, coaching or mentoring, as appropriate).
7. Act as Franchise Liaison (maintain links with Bios, DM, DBP as appropriate) to one of the Global IIS Franchise teams
8. Act as liaison between clinical and DS+E teams, and safety document writing teams to ensure full integration of teams and timely delivery of final documents.
9. May represent RW and Company at external professional meetings and conferences, as required.
10. May act as deputy for functional or operational manager.
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Candidate Profile:
Education (minimum/desirable): Minimum. Life sciences higher degree (or equivalent)
Languages: Excellent written and oral English
Experience/Professional requirement: 1. Strong medical writing experience or other relevant pharma or research environment industry experience combined with in-depth scientific, therapeutic area, and regulatory knowledge, plus comprehensive professional knowledge of the medical writing processes.
2. Ability to coach, mentor, and lead global cross-functional teams. Strong leadership skills .and preferably line management experience
3. Extensive experience of data interpretation and presentation of safety documents for pre and post-marketing activities.
4. Expertise in the preparation of documents for submission to health authorities.
5. Excellent knowledge of safety document requirements, creation, management and publishing processes and tools.
6. Experience with matrix management and global environment.
Additional Information:
Location: Hyderabad
Education: B.Pharm, B.Sc
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Medical
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID: 77296BR
End Date: 12th July, 2011
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