Company Description:
MakroCare is an Expert Strategic Development and Commercialization Global Partner for Pharmaceutical,
Biotechnology and Medical Device industries. Our Experience, Programs and Processes bring a New
Dimension to Development Strategy, Regulatory/Risk Planning & Management, Clinical Research,
Medical/Scientific Support and Emerging Region Expansion
Job description: Medical Writer (CSR)
- Writing and reviewing clinical/regulatory documents such as clinical trial protocols, clinical study reports (CSR), investigator brochures, informed consent forms, and according to ICH or other guidelines.
- Module Drafting (2.4, 2.5. 2.6 & 2.7).
- Publication manuscripts, abstracts, posters (content writing) and presentations participate in post-market surveillance activities by conducting routine systematic literature reviews (e.g. Screening of articles against inclusion/exclusion criteria, extracting data from included studies,
- interpreting study results and preparing summaries into formal reports) for specific medical device groups or subgroups.
- Develop templates for reports and other regulatory documents.
Education & Qualifications:
- Any UG/PG in Life Science background
- Minimum of 1-3 years of experience in the Medical Writing with in CSR field.