Are you a qualified medical professional looking to advance your career in the pharmaceutical industry? Quantys Clinical Private Limited, located in Gandhidham, Gujarat, is currently seeking a Medical Writer to join their dynamic team. This is an excellent opportunity for individuals with a background in medicine or pharmacy who possess strong writing skills and a passion for clinical research.
About Quantys Clinical Private Limited
Quantys Clinical is a prominent Contract Research Organisation (CRO) dedicated to providing top-tier clinical research services. With a focus on innovation and integrity, our organization is known for its commitment to advancing healthcare through research. By joining our team, you will contribute to significant clinical trials that aim to improve patient outcomes.
Position Overview
As a Medical Writer, you will play a crucial role in the inception, design, and documentation of clinical trials. Your responsibilities will extend to various vital documents, including the development of clinical trial protocols, informed consent forms (ICF), clinical study reports (CSR), and safety updates. We are looking for candidates with 3 to 7 years of experience in medical writing within the clinical research field.
Key Responsibilities
- Clinical Trial Documentation: Develop and finalize essential clinical trial documents such as synopsis, protocol, ICF, case report forms (CRF), Investigator’s Brochure (IB), annual study reports, periodic safety update reports, SAE narratives, and final trial reports.
- Safety Literature Review: Analyze and write narratives for individual case reports and serious unexpected adverse reactions (SUSARs) for the US-FDA.
- Med Watch Submissions: Complete and submit Med Watch forms while ensuring MedDRA coding complies with US-FDA regulations.
- Trial Management: Coordinate the timely retrieval of documents from clinical trial sites, Principal Investigators (PIs), other CROs, and Site Management Organizations (SMOs).
- Communication: Liaise effectively with ethics committees, trial sites, CROs, SMOs, and vendors to ensure seamless execution of clinical trials.
- Tracking and Reporting: Maintain Trial Master Files (TMF), manage investigational products, and oversee processes such as labeling, blinding, randomization, and dispatch.
- Regulatory Compliance: Ensure all documentation aligns with regulatory guidelines and is submitted within stipulated timelines. Manage the registration of clinical trials with the Clinical Trials Registry India (CTRI).
- SOP Implementation: Inception and implementation of Standard Operating Procedures (SOP) and Work Instructions (WI) for efficient clinical trial management.
Desired Qualifications
- Educational Background: Candidates should possess a Bachelor’s or Master’s degree in Pharmacy (B. Pharma, M. Pharma), Dentistry (BDS), or Medicine (MBBS).
- Experience: A minimum of 3 to 7 years of experience in medical writing, particularly in clinical trials.
- Skills: Strong writing, analytical abilities, attention to detail, and excellent communication skills are integral to success in this role.
Why Join Us?
Joining Quantys Clinical means becoming part of a team committed to excellence in clinical research. We offer a collaborative work environment that encourages innovation and professional growth, along with competitive remuneration and benefits. Being part of our team allows you to contribute to groundbreaking research that saves lives and enhances healthcare solutions worldwide.
How to Apply
If you are passionate about medicine and possess the qualifications we are looking for, we invite you to apply for the Medical Writer position at Quantys Clinical Private Limited. Please submit your resume and a cover letter outlining your relevant experience and why you believe you would be a great fit for our team.
Apply at email : hr@quantysclinical.com and info@quantysclinical.com
