Medical Writer Job at Zydus
A rare chance has emerged for aspiring medical professionals as Zydus MedTech seeks a Medical Officer in Ahmedabad. This Medical Writer Job is ideal for candidates with an MBBS or BHMS degree and 0-3 years of experience in medical device safety or medical writing. Interested applicants are encouraged to apply before the deadline.
About Zydus:
Zydus MedTech is a prominent player in the medical device industry, operating under the Zydus Group in Ahmedabad, Gujarat, India. The organization is dedicated to innovation and excellence in healthcare, focusing on the development and safety of medical devices to enhance patient outcomes. With a commitment to regulatory compliance and quality, Zydus MedTech plays a crucial role in the healthcare sector.
Job Details:
- Designation: Medical Writer
- Location: Ahmedabad, Gujarat, India
- Job ID: JOB11020
- Division: MedTech Office
- Employee Type: P-P8-Probationer-HO Executive
Job Description:
The Medical Officer will be responsible for authoring, updating, and reviewing medical device-focused documents in the regulatory and safety space. Key responsibilities include preparing Clinical Evaluation Plans (CEP), Clinical Investigation Plans (CIP), and Individual Case Safety Reports (ICSRs), among others.
Key Responsibilities:
- Medical Writing: Authoring and reviewing regulatory documents such as Clinical Evaluation Reports (CER) and Post-Market Clinical Follow-Up (PMCF) reports.
- Safety Associate for materiovigilance: Processing Individual Case Safety Reports (ICSRs) of adverse device incidents.
- Regulatory Compliance: Ensuring adherence to India MDR, EU MDR, ISO 13485, and company SOPs.
- Collaboration: Working with Regulatory Affairs, Quality, and R&D teams to align clinical data with safety and performance requirements.
- Signal Detection: Performing trending analysis to identify potential safety risks associated with devices.
- Follow-up: Communicating with healthcare professionals to gather additional information on adverse events in the Non-Clinical Job.
- Literature Science: Conducting systematic literature searches and preparing literature summary reports.
- Safety Reporting: Generating human consequence reports of complaints related to adverse device incidents.
Eligibility Criteria for the Medical Writer Job:
- Education: Medical Graduation – only MBBS or BHMS candidates may apply; Pharm D candidates with relevant exposure may be considered.
- Experience: 0-3 years in Medical Devices Safety Functions or Medical Writing.
- Knowledge: Deep understanding of EU MDR requirements and clinical data interpretation.
- Skills: Exceptional writing/editing skills, proficiency in English; knowledge of French/Portuguese is an advantage.
