Scientific Writer – Medical Devices | Kolhapur | MD / PhD in Biomedical Engineering

Cactus Communications Pvt. Ltd. Hiring Experienced Scientific Writer – Medical Devices at Kolhapur in 2020 – MD, PhD in Biomedical Engineering. Applications are Invited for Those Candidates are fulfill all requirements of this post. Applicants are Comfortable for Join the Team and Take Initiative for the Customer Task.

Company Name: Cactus Communications Pvt. Ltd.

Company Website:

Company Type: MNC

Position: Scientific Writer – Medical Devices

No. of Vacancies: Not Mentioned

Experience: 1+ Years

Location: Kolhapur

Male/Female: Both

Qualification: MD, PhD in Biomedical Engineering or a similar degree with knowledge of                          clinical research, and first-author publications in international peer-                                    reviewed journals

Age: Not Mentioned

Job Timing: Full Time

Salary: Not Disclosed

Scientific Writer – Medical Devices

Job Description: 

CACTUS is looking to add an experienced Scientific Writer to it’s team of CER writers. The SW – CER will be involved in development of high-quality Clincial Evaluation Reports, Clinical Evaluation Plans, and related documents in compliance with MedDev 2.7.1 Rev 4 guidance.

Responsibilities and Duties:

  • Ensure timely production of high quality CERs for devices across therapeutic areas
  • Screen and summarize literature for relevant clinical data
  • Review literature to elucidate the clinical problem and current treatment techniques
  • Study and report device characteristics and instructions for use
  • Evaluate data for similar competitor devices
  • Summarize post-marketing surveillance and risk management data for the target device
  • Work with senior writers to prepare documents that meet client expectations in terms of content, format, and presentation
  • Train and mentor junior writers and perform detailed reviews of their deliverables

Qualifications and Skills:

  • MD, PhD in Biomedical Engineering or a similar degree with knowledge of clinical research, and first-author publications in international peer-reviewed journals
  • A Master’s degree with clinical research exposure and significant publications experience can also be considered
  • 1-2 years of regulatory writing experience, with some exposure to medical devices
  • 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.
  • Experience across document types and therapeutic areas/diseases/drug classes
  • Ability to understand and interpret complex clinical trial data
  • Clear, concise scientific style of writing with a high level of attention to detail
  • Excellent written and oral English language skills
  • Be self-motivated and eager to take on challenges
  • Ability to work under tight timelines and manage multiple tasks

Work Remotely: Yes

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