Medical Writer

• As a Medical Writer at MakroCare, the role in the development and review of clinical and regulatory documents essential for the advancement of medical research and product development. Your responsibilities will include writing and reviewing a variety of documents such as clinical trial protocols, clinical study reports, investigator brochures, and informed consent forms, ensuring adherence to established guidelines and regulations.
• Additionally, you will contribute to post-market surveillance activities, participate in manuscript and abstract writing, and assist in the development of templates for regulatory documents. This position offers an exciting opportunity to utilize your expertise in medical writing to support the development of innovative healthcare solutions.

Responsibilities

• Write and review clinical/regulatory documents such as clinical trial protocols, clinical study reports/Clinical evaluation reports, investigator brochures, and informed consent forms in accordance with ICH or other relevant guidelines.
• Draft and document CSR (Clinical Study) and CER (Clinical Evaluation) modules.
• Participate in the writing of publication manuscripts, abstracts, posters, and presentations.
• Conduct routine systematic literature reviews for specific medical device groups or subgroups, including screening articles against inclusion/exclusion criteria, extracting data from included studies, interpreting study results, and preparing summaries into formal reports.
• Develop templates for reports and other regulatory documents.

Education & Qualifications

• Bachelors or Masters degree in Life Sciences or BDS/MDS (Bachelors/Masters of Dental Surgeon)
• Minimum of 1-3 years of experience in Medical Writing (CSR/CER) or a related field.

Skills: