Location
Secunderabad | India
Job description
About The Role
Senior Medical Writer II
Location – Hyderabad Hybrid
About the Role:
This role is responsible to author, review and independently manage high quality clinical documents: Clinical Study Reports (CSR) including narratives, Protocol, Informed Consent Form (ICF).
Your 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.
- 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. Role Requirements What You'll bring to the role:
Essential:
- Minimum science degree or equivalent, B.Sc./equivalent with 10 years Clinical Research (CR) experience, M.Sc./M.Pharma +8 years of clinical research (CR).
- Excellent written and oral English Minimum: Minimum science degree or equivalent, B.Sc./equivalent with 10 years Clinical Research (CR) experience.
Desirable requirements:
- M.Sc./M.Pharma +8 years of clinical research (CR) experience Desired.
- Doctoral Degree or Qualification in Medical Sciences (MBBS/MD/equivalent) PhD + 6 year of CR experience, MBBS/equivalent + 6 year of CR.
Why Novartis: Our purpose is to reimagine medicine to improve and extend people's lives and our vision is to become the most valued and trusted medicines company in the world. How can we achieve this With our people. It is our associates that drive us each day to reach our ambitions. Be a part of this mission and join us! Learn more here:
You'll receive: You can find everything you need to know about our benefits and rewards in the Novartis Life Handbook.
Commitment to Diversity and Inclusion:
Novartis is committed to building an outstanding, inclusive work environment and diverse teams' 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:
Division Operations
Business Unit Global Business Solutions
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 tags
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