Freelance Medical Writer - Clinical Evaluation Reports
Job Title Freelance Medical Writer - Clinical Evaluation Reports
Location Mumbai
Salary Rs 200000 - 400000
Experience 1 - 2 years
Shift NA
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Job Details



Qualifications

1) An MD, PhD in Biomedical Engineering or similar degree with knowledge of clinical research, and first-author publications in international peer-reviewed journals

2) A Master’s degree with clinical research exposure and significant publications experience can also be considered

3) 5+ years of CER writing experience in a medical device company, CRO, or agency

4) 1-2 years of regulatory writing experience, with some exposure to medical devices

5) Advanced knowledge of 510(k), MedDEV 2.7.1 Rev 4, MDR, and other relevant medical device regulations as well as knowledge of ICH and GCP guidelines.

6) Experience across document types and therapeutic areas/diseases/drug classes

7) Ability to understand and interpret complex clinical trial data

8) Clear, concise scientific style of writing with a high level of attention to detail

9) Excellent written and oral English language skills

10) Be self-motivated and eager to take on challenges

11) Ability to work under tight timelines and manage multiple tasks

12) Experience of working with offshore writers will be an added advantage

13) Willingness to travel to India office up to 2 times a year

Skills

1) Strong Communication skills.

2) Interpersonal skills.

Role

1) Ensure timely production of high quality CERs for devices across therapeutic areas

2) Screen and summarize literature for relevant clinical data

3) Review literature to elucidate the clinical problem and current treatment techniques

4) Study and report device characteristics and instructions for use

5) Evaluate data for similar competitor devices

6) Summarize post-marketing surveillance and risk management data for the target device

7) Work with India-based junior and senior writers to prepare documents that meet client expectations in terms of content, format, and presentation

No .of vacancies

1 vacancies

Perks

1) Global Exposure.

2) Culture & Team.

3) Learn & Grow.

4) Satisfaction & Recognition.




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