27/01 Manu

Views:337 Applications:9 Rec. Actions:Recruiter Actions:6

IQVIA - Medical Writer - B.Pharma/M.Pharma (5-9 yrs) Premium

Gurgaon/Gurugram/Mumbai/Noida Job Code: 8964

Education : B. pharma, BSC, B.tech-Biotechnology, M.pharma, MSC, M.tech-biotecnology

Experience : 5 to 9 years

Job Description:

1. Acts as Lead Medical Writer and performs competently on straightforward projects, with guidance from senior staff as required. Takes responsibility for preparation of assigned documents to a high standard, working in accordance with IQVIA SOPs and the customer's requirements. Identifies project needs, tracks project timelines and implements client requests with senior review

2. Participates in both internal and external project team meetings and liaises directly with the customer on medical writing issues, as appropriate and with senior support as needed

3. Arranges appropriate internal review of assigned documents and takes responsibility for on-time delivery

4. May perform QC review of documents or parts of documents prepared by more senior staff

5. Takes responsibility for managing day-to-day workload for assigned tasks and projects, in collaboration with senior staff

6. Keeps abreast of current data, trends, medical writing/regulatory knowledge, developments and advances in area of drug development/medical writing

7. Complies with Company SOPs and participates in the implementation of new SOPs

Required knowledge, skills & abilities:

1. Excellent standard of written English, and ability to communicate fluently and effectively in English, both in writing and verbally

2. Familiarity with the structural and content requirements of study reports, protocols, and similar documents

3. Ability to integrate, interpret, and summarize data from a variety of sources in a clear and concise manner

4. Competence in completing a good first draft clinical study report in a routine therapeutic area within are reasonable timeframe with limited guidance

5. Good understanding of common statistical methods used in clinical trials and interpretation of their results

6. Ability to give a simple presentation to a project team and/or customer, e.g. on Medical Writing processes

7. Ability to identifying consistencies and deficiencies in statistical output

8. Ability to work on several projects at once while balancing multiple and overlapping timelines

9. Demonstrated abilities in collaboration with others and independent thought

10. Knowledge of regulations relevant to medical writing

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