Novartis Medical Writing Job For Life Sciences, Apply Online
Novartis Medical Writing Job For Life Sciences, Apply Online. Novartis Jobs. Novartis MSc & PhD Life Sciences Jobs. Novartis Life Sciences Senior Medical Writer II Recruitment, Apply Online. Interested and eligible applicants can check out all of the details on the same below
Name of the Post – Senior Medical Writer II
Job ID – 357265BR
Country – India
Work Location – Hyderabad, AP
Company/Legal Entity – Nov Hltcr Shared Services Ind
Functional Area – Research & Development
Job Type – Full Time
Employment Type – Regular
Shift Work -No
Early Talent – No
Job Purpose:
To write, review and manage the preparation of high-quality clinical documents for cpos and global organizations. Provide authoritative documentation related consultancy to other line functions.
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, and Informed Consent Forms (ICF).
- To write CTD modules and other safety documents (DSURs, RMPs) independently. Liaise with medical/clinical experts, statisticians, and investigators in concept development when the protocol is being developed and work in a collaborative fashion for global/CPOs
- Contribute to the planning of data analyses and presentations 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 organizations and ensure medical writing resource allocation to studies within these programs.
- Supervise outsourcing to external medical writers, if necessary in conjunction with mentoring medical writers. 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.
Minimum requirements –
- A minimum university life science degree or equivalent is required. An advanced degree or equivalent education/degree in life sciences/healthcare 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
Editor’s Note: Novartis Medical Writing Job For Life Sciences, Apply Online. Please make sure that you are subscribed to the Biotecnika Times Newsletter and our YouTube channel to be notified of all of the latest in the industry. Follow us on our social media like Twitter, Telegram, Facebook and Instagram.
