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Medical Writer
hace 1 semana
We're hiring
At Cognizant we have an ideal opportunity for you to be part of one of the largest companies in the digital sector worldwide.
A Great Place To Work where we look for people who contribute new ideas, experiencing a dynamic and growing environment.
At Cognizant we promote an inclusive culture, where we value different perspectives providing career growth and development opportunities. #WelcomeToCognizantWe have an exciting opportunity for an exceptional individual to work supporting one of our clients as a
Medical Writer
Principal Accountabilities
Write and review the above mentioned documents: study protocol, clinical study reports, inform consent forms, clinical modules (2.5 and 2.7 summaries), lay summaries, CSR narratives, Investigator's brochure, Briefing books and/ or anonymization activities (EMA Policy 0070)
- If required and as applicable, manage some of the subcontracted medical writing activities with offshore team
- Liaise with sponsor project managers, data managers, statisticians to deliver high quality results as appropriate. Coordinates for document authoring, review and approval (endtoend activities).
- Demonstrate knowledge of assigned therapeutic areas and assigned products.
- Have basic knowledge of key statistical concept.
- Ability to compare and interpret data across different MAA, and its logical representation.
- Research, develop and write content that is scientifically accurate, evidencebased, grammatically accurate, referenced using appropriate sources, and consistent with quality standards.
- Be able to clearly communicate medical scientific concepts in a condensed way.
- Demonstrate the flexibility/adaptability necessary to function on different therapeutic teams as needed.
- Responsible for consistency, checks documents for data errors and uniformity with source documents.
General Requirements
- Wellversed with International Conference on Harmonization (ICH) Good Clinical Practice (GCP) guidelines and regulatory requirements for scientific documents
- Strong English writing capabilities
- Solid medical/ scientific knowledge in any of Oncology, Inflammatory, Rare Diseases, neuroscience and cardiovascular therapeutic areas
- Autonomy
- Excellent oral English communication skills
Why Cognizant?
- Improve your career in one of the largest and fastest growing IT services providers worldwide_
- Receive ongoing support and funding with training and development plans_
- Have a highly competitive benefits and salary package_
- Get the opportunity to work for leading global companies_
- We are committed to respecting human rights and build a better future by helping your minds and the environment _
- We invest in people and their wellbeing. _
- We create conditions for everyone to thrive. We do not discriminate based on race, religion, color, sex, age, disability, nationality, sexual orientation, gender identity or expression, or for any other reason covered._
- At Cognizant we believe than our culture make us stronger_
- Join us now_
Employee Status :
Full Time Employee
Shift :
Day Job
Job Posting :
Jan
**About Cognizant
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