Medical Writer
4 days ago
Hiring for top MNC for Hybrid role for PAN India
- Location - Pan India
- Mode - Hybrid (3 days WFO, 2 days WFH)
- Exp - 4 to 7 Years
- CER, PSUR & PMCF
- Notice period not more than 30 days.
Job Description :
- Perform CER & Post market documents gap assessment
- Ability to draft and review CER, Post market plans & report such as PMS-Plan, PMS Report, PSUR, PMCF Report
- Identify appropriate sources of relevant data, interpret, evaluate and incorporate information from various sources including literature, clinical data, and medical references.
- Collaborates with cross functional teams such as PMS, Medical affairs, Literature search, Risk management, R&D, Sales & Marketing, etc.
- Schedules and conducts document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes
- To interpret results and ensure report is in sync with Plan and regulatory guidelines and statistical interpretations,
- Alert relevant stakeholders of potential safety issues
- Adhering to company policies and procedures and maintaining customer record for tracking and retrieval.
- Review the work performed by peers
- Co-ordinate with CFTs for ensuring timely input and review of regulatory documents
- Overall responsible for achieving Client’s service level expectations
- Good interpretation skill for regulatory guidance documents such as 2017/745, Med Dev., QSR, ISO 13485, ISO 14971 etc.
- Prior exp in EU MDR Gap assessment and Remediation.
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