Senior Medical Writer 2

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. 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. : 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.