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Senior Medical Writer 2
Sandoz
posted 1mon ago
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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.
Job Description
Senior Medical Writer 2
Location - Hyderabad #LI Hybrid About the Role : 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.
Location - Hyderabad #LI Hybrid About the Role : 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
- Act as project medical writer for various programs in CPOs/global organization and ensure medical writing resource allocation to studies within these programs
- Supervise outsourcing to external medical writers, if necessary in conjunction with mentoring medical writer
- Follow and track clinical trial milestones and resource requirements for assigned projects Training and mentoring of associates as required
- Contribute to cross-functional communication to optimize feedback and input towards high quality documents
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.
- 4 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.
- 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 /experience in submission documents
- Strong knowledge of and experience in global regulatory environment and processes (key regulatory bodies, key documents, approval processes, safety reporting requirements).
- Broad knowledge and future oriented perspective
Desirable Requirements:
- Demonstrated ability to establish effective working relationship in a matrix and multicultural environment.
- Experience in managing global, cross functional teams or simple global projects.
- Strong customer-oriented mindset.
Employment Type: Full Time, Permanent
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Flexible timing
Monday to Friday
No travel
Day Shift
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