Medical Device

2 hours ago

Pune, Maharashtra, India Global IT Solutions Full time ₹ 40,000 - ₹ 1,60,000 per year

Role Description

This is a full-time on-site role for a
Medical Device - Medical Writer (PMS)
located in Pune. The Medical Writer will be responsible for creating scientific and medical content, conducting research, and writing medical communications. Day-to-day tasks include developing and editing documents related to post-market surveillance (PMS) and ensuring regulatory compliance in accordance with industry standards.

Location: Pune

Qualification: Graduate in Biomedical Engineering , Graduate in Pharmacy, Post-Graduate in Life Science

AA - Experience: Fresher

Budget: 3-4 LPA

B2 - Experience: 5-8 years (Experience in drafting Post-market surveillance reports for Medical Devices)

Budget: 10-16 LPA

Notice Period: Immediate Joiners

Skills Required:

  • Ability to assess technical and Clinical/Medical data and propose solutions.

Roles and Responsibilities:

1) Ability to draft, update and review PMS Plan, PMS Report/PSUR, PRER, and the Canada Summary Report for medical devices

2) Identify appropriate sources of relevant data, interpret, evaluate and incorporate information from various sources including literature, clinical data, and medical references.

3) Interpret, compile and submit right set of clinical and post market documents to respective regulatory authorities for international regulatory submissions.

4) Collaborates with cross functional teams such as PMS, Medical affairs, Literature search, Regulatory, Risk management, R&D, Sales & Marketing, etc.

5) Supporting in responding inquiries/clarification request received from regulatory authorities

Qualifications

  • Scientific Writing and Medical Writing skills
  • Medical Communications and Writing skills
  • Experience in conducting Research
  • Excellent written and verbal communication skills
  • Ability to work independently and collaboratively
  • Experience in the medical device industry is a plus
  • Bachelor's or advanced degree in Life Sciences, Medicine, or related field

Interested candidates can share me their resume at or drop resume at or DM.

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