Senior Medical Writer II

Oct 05, 2021

Job Description

Your responsibilities include, but are not limited to:

• 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. Maintain audit, SOP and training compliance.

Diversity & Inclusion / EEO

Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.

Minimum Requirements

• ≥ 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; Experience in managing global, cross functional teams or simple global projects. Ability to work in teams.

769 million lives were touched by Novartis medicines in 2020, and while we’re proud of this, we know there is so much more we could do to help improve and extend people’s lives.
We believe new insights, perspectives and ground-breaking solutions can be found at the intersection of medical science and digital innovation. That a diverse, equitable and inclusive environment inspires new ways of working.
We believe our potential can thrive and grow in an unbossed culture underpinned by integrity, curiosity and flexibility. And we can reinvent what's possible, when we collaborate with courage to aggressively and ambitiously tackle the world’s toughest medical challenges. Because the greatest risk in life, is the risk of never trying! Imagine what you could do here at Novartis!
Commitment to Diversity & Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse team’s representative of the patients and communities we serve.
Join our Novartis Network : If this role is not suitable to your experience or career goals but you wish to stay connected to hear more about Novartis and our career opportunities, join the Novartis Network here:
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Hyderabad, AP
Research & Development
Full Time
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Senior Medical Writer II

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