HCLTech is a global leader in technology and IT services, driving innovation and delivering transformative solutions to its clients worldwide. The company’s expertise spans across multiple domains, including healthcare and life sciences. HCLTech offers its employees opportunities to work on cutting-edge projects in a collaborative, dynamic environment.
For professionals in medical writing, HCLTech presents a chance to contribute to impactful healthcare projects.
Job Responsibilities for Medical Writer
The selected candidate will undertake key responsibilities, including:
- Clinical Evaluation Reports (CER) and Plans (CEP):
- Creation and updating of CEPs and CERs for medical devices, adhering to MEDDEV Rev 4 and MDR regulations.
- Post-Market Surveillance (PMS):
- Handling PMS documentation such as PMS Plans, Reports, Periodic Safety Update Reports (PSUR), Post-Market Clinical Follow-up (PMCF), and Summary of Safety and Clinical Performance (SSCP).
- Clinical Documentation:
- Developing protocols, clinical study reports, investigator’s brochures, clinical evidence summaries, and risk-benefit analysis reports.
- Literature Review and Data Analysis:
- Conducting literature searches and summarizing data from clinical studies.
- Reviewing medical journals and technical reports.
- Collaborative Activities:
- Working closely with doctors, researchers, and medical personnel to create comprehensible documents.
- Attending project meetings, medical discussions, and client teleconferences.
- Regulatory Compliance:
- Reviewing and updating clinical documents like case report forms (CRFs), informed consent forms (ICFs), and protocols.
Qualifications Required
Candidates should meet the following criteria:
- Experience in clinical evaluation and medical writing activities.
- Familiarity with MEDDEV Rev 4 and MDR regulations.
- Understanding of PMS and PMCF documentation requirements.
- Expertise in literature reviews, statistical analysis, and clinical data summarization.
Key Skills Needed
- Strong understanding of medical terminology and regulatory guidelines.
- Excellent writing, editing, and communication skills.
- Analytical thinking and data interpretation capabilities.
- Ability to collaborate across teams and meet deadlines.
Walk-In Drive
- Walk-In Details:
- Date: 14th December 2024
- Time: 9:30 AM – 3:00 PM
- Venue:
HCL Technologies Ltd.
H01B, HITEC CITY-2,
Survey No. 30, 34, 35 & 38,
Phoenix Infocity Pvt. Ltd.,
Madhapur, Hyderabad-500081, Telangana, India
- Contact Information:
- Recruiter Name: Aswathy Rajan
- Contact Persons: Priyanka Jamanjyothi, Meenakshi Biradar
- Documents to Carry:
- Updated resume.
- Relevant certifications and proof of experience.
- A valid photo ID.