16625-sr Medical Writer

2 days ago

Thane, India IQVIA Full time

Qualifications
- Bachelor's Degree Bachelor's Degree in life sciences related discipline or related field (required); Req
- Master's Degree Master's Degree in life sciences related discipline or related field (Pref);
Pref
- Ph.D. Ph.D. in life sciences related discipline or related field (Pref); Pref
- Typically requires at least 5 years of highly relevant experience and related competency levels.
- In-depth knowledge of the structural and content requirements of clinical study reports, protocols, and similar documents and ability to identify deficiencies, errors, and inconsistencies in a protocol or report.;
- Good understanding of common statistical methods used in clinical trials and/or interpretation of their results.;
- Ability to effectively review a statistical analysis plan and to identify deficiencies, errors, and inconsistencies in statistical output
- Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner.;
- Significant experience as a lead writer in preparing CSRs and protocols, with consistently positive feedback from customers and colleagues.;
- In depth knowledge of drug development, medical writing, and associated regulations. Good understanding of statistical principles and of medical terminology across a range of therapeutic areas.;
- Excellent written and oral communication skills including grammatical/technical writing skills.
- Excellent attention to detail and accuracy.
- Confident and effective communication and negotiation skills with customers and project managers.
- Able to deliver difficult messages in constructive manner.
- Demonstrates initiative and sound judgement when faced with less familiar project/document situations or challenges.
- Demonstrated abilities in collaboration with others and independent thought.
- Demonstrates confidence and maturity in most routine medical writing situations.
- Demonstrates good judgement in requesting input from senior staff.
- Ability to establish and maintain effective working relationships with coworkers, managers and customers.
- Ability to effectively manage multiple tasks and projects.
- Ability to proactively evaluate risks and potential issues and seek solutions and discuss appropriately with colleagues and customers.
- Must be computer literate.

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