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
Job Description
To write, review and/or manage the production of high quality clinical documentation for submission to CPO’s and global organization . To provide authoritative documentation related consultancy to other line functions. To coach/mentor and/or train less experienced medical writers.
1. To author, review and independently manage high quality clinical documents: Clinical Study Reports (CSR), Protocol, Informed consent document (ICD).
2. Liaise with global/CPOs medical/clinical experts, statisticians, investigators in concept development when protocol is being developed and work in a collaborative fashion
3. Major contributor to planning of data analyses and presentation to be used in CSRs
4. Program Writer for programs, ensuring adequate medical writing resources are available for assigned program and consistency between documents.
5. Ensuring compliance of documentation to internal company standards and external regulatory guidelines.
6. Support process improvement by contributing and/or taking the lead (e.g. review of SOPs, templates).
7. Can coach/mentor less experienced medical writers.
8. Contributor to cross-functional communication to optimize feedback and input towards high quality documents.
9. Maintain audit, SOP and training compliance.
Candidate Profile
Minimum university life science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/medicine/pharmacy is desirable. Fluent English (oral and written).
• PhD or degree in medicine (MBBS/MD) with 2 to 4 years of relevant experience
• ≥ 4 years medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus in-depth knowledge of medical writing processes.
• Excellent communication skills (written, verbal, presentations)
• Strong operational knowledge of clinical trial reporting.
• Strong knowledge of biostatistics principles.
• Strong ability to prioritize and manage multiple demands and projects.
• Strong knowledge of and repeat experience in global registration of drugs (simple submissions).
• Strong knowledge of and experience in global regulatory environment and processes (key regulatory bodies, key documents, approval processes, safety reporting requirements).
• Ability to define and solve complex problems (“Problem-solver”)
• Broad knowledge and future oriented perspective
• Ability to drive and manage organizational and team performance across cultures.
• Proven track record in matrix environment
• Some experience in managing global, cross functional teams or simple global projects.
• Ability to motivate and coach people.
Additional Information:
Experience: 2-4 years
Location: Hyderabad
Industry Type: Pharma/ Biotech/Clinical Research
Functional Area: Medical Writing
Division: Pharma
Job Type: Full Time
Employment Type: Permanent
Job ID: 137370BR
End Date: 31st May, 2014
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