Under supervision and with guidance from more senior service line colleagues:
- Undertakes project specific activities with supervision from seniors at high quality and in defined timelines according to standard processes and operating procedures.
- Writing, editing and summarising clinical documents such as clinical study reports, narratives, clinical summaries or others
- To produce external scientific communications / publications (including but not limited to abstracts and presentation material like slide sets).
- Developing journal manuscripts and other clinical trial related documents to international specifications
- Systematically perform quality control checks of documents prepared by other Associates’ against pre-specified check-list generated in the project and follow up till final submission
- Perform detailed analyses on a planned and ad hoc basis, relating to the medical writing processes and their outputs
- Educational qualifications: A minimum of a scientific graduate degree from a well-known institution. A second degree and/or proven track record of working in biomedical science would be advantageous.
- Candidates will have any one of the following qualifications from a reputed university:
Masters/ Bachelors in Pharma
Masters in Biotechnology
Masters in Chemistry/ Bio-Chemistry
Ph.D/Post Graduate degree in Life Sciences or MBBS
- Candidates with exposure to medical writing, either as a part of a pharmaceutical/ CRO company or as a freelancer will be preferred
- Proven track record in writing clinical trial protocols and clinical study reports preferred
- Growing knowledge of regulatory requirements or guidance for service line area
- Good understanding of clinical development processes including principles of clinical study operations, and ICH-GCP guidelines
Key skill requirement
- Clear written and verbal communication skills
- Working knowledge of basic computer applications, e.g. MS Word/ PowerPoint/ Excel, will be required
- Core competencies for this role include:
- Analytical capabilities, familiarity and comfort with scientific and clinical data.
- Professional service mentality – Demonstrates commitment and full ownership of the work allocated,
- Commitment to highest quality outputs, including high attention to detail
- Enthusiasm and pro-activity
- Team collaborators, ability to be successful working in teams
- 2 to 5 yrs
- As per Industry Standards
- Bengaluru/ Bangalore ,Gurgaon
- :Law/Legal Firms
- Business Content Developer
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