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Senior Medical Writer 1
Sandoz
posted 1mon ago
Job Role Insights
Flexible timing
Key skills for the job
Job Description
To write, review and manage the preparation of high quality clinical documents for CPO s and global organization. Provide authoritative documentation related consultancy to other line functions.
Key Responsibilities:
- To author, review and independently manage high quality clinical documents: Clinical Study Reports (CSR) including narratives, Protocol, Informed Consent Form (ICF).
- To write CTD modules and other safety documents (DSURs, RMPs) independently
- Liaise with medical/clinical experts, statisticians, investigators in concept development when protocol is being developed and work in a collaborative fashion for global/CPOs
- Contribute to planning of data analyses and presentation to be used in CSRs
- Ensure compliance of documentation to internal company standards and external regulatory guidelines.
- Supervise outsourcing to external medical writers, if required.
- Training and mentoring of associates as required.
- Contribute to cross-functional communication to optimize feedback and input towards high quality documents. Maintain audit, SOP and training compliance.
Commitment to Diversity & Inclusion: :
We are committed to building an outstanding, inclusive work environment and diverse teams representative of the patients and communities we serve.
Essential Requirements:
- Minimum university life science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/medicine/pharmacy is desirable.
- 3 years of regulatory medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge, plus in-depth knowledge of medical writing processes.
- Good communication skills (written, verbal, presentations)
- Good operational knowledge of clinical trial reporting.
- Good knowledge of biostatistics principles.
- Strong ability to prioritize and manage multiple demands and projects.
- Knowledge of and experience in global regulatory environment and processes (key regulatory bodies, key documents, approval processes, safety reporting requirements).
- Good experience in managing global, cross-functional teams or simple global projects.
Desirable Requirements:
- Demonstrated ability to establish effective working relationship in a matrix and multicultural environment.
- Demonstrated presentation and diplomacy skills.
- Strong customer-oriented mindset.
Employment Type: Full Time, Permanent
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Flexible timing
Monday to Friday
No travel
Day Shift
Sandoz Benefits
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Competitive compensation Pay equity Pay for sustainable performance Differentiated benefits and wellbeing programs Values & integrity Balanced rewards
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Scientist - Technical Development
5-8 Yrs
Warangal, Hyderabad / Secunderabad, Nizamabad
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