Senior Medical Writer - BABE/CRO

Job Title: Senior Medical Writer for BABE/CRO

Company: QPS Bioserve

Location: Hyderabad, India

Experience: 5 - 10 years

Employment Type: Full-Time, Permanent

Industry: Clinical Research / Contract Research

Job Overview:

QPS Bioserve is seeking a Senior Medical Writer for its BABE (Bioavailability/Bioequivalence) and Contract Research Organization (CRO) services. This role requires expertise in clinical study design, medical writing, and scientific communication. The successful candidate will be responsible for guiding the medical writing team, ensuring compliance with regulatory requirements, and contributing to the development of accurate, scientifically sound clinical study reports.

Key Responsibilities:

• Clinical Study Design: Identification and development of clinical study designs according to global customer requirements and regulatory standards.
• Leadership & Team Guidance: Lead and guide the medical writing team on scientific and regulatory aspects of clinical studies, ensuring high-quality deliverables.
• Collaboration: Work closely with clinical bioanalytical teams to continuously improve the medical writing process.
• Pharmacy & Equipment Compliance: Oversee the qualification and calibration of pharmacy equipment and instruments used in clinical studies.
• Regulatory Evaluation: Assess clinical study designs, ensuring they comply with global regulatory guidelines and best practices.
• Software Procurement & Validation: Identify, procure, and validate appropriate pharmacokinetics and statistical software for analysis.
• Content Review & Delivery: Review and deliver scientifically accurate content aligned with study objectives and sponsor specifications.
• Project Management: Manage the scheduling, budgeting, and resource allocation for medical writing, pharmacokinetic, and statistical analysis projects.
• Internal & External Communication: Ensure clear and efficient communication regarding study-related matters within and outside the organization.
• Quality Control: Conduct independent quality control measures in medical writing, pharmacy, pharmacokinetics, and statistical analysis.
• Training: Train employees on relevant procedures, regulations, and customer requirements to maintain high standards.

Preferred Candidate Profile:

• Educational Qualifications:
• UG: B.Pharma in any specialization
• PG: M.Pharma in any specialization, PG Diploma in any specialization, MS/M.Sc (Science) in any specialization
• Experience: 5 - 10 years in medical writing, clinical research, or a related field, particularly in BABE/CRO settings.

About QPS Bioserve:

QPS Bioserve is a leading global Contract Research Organization (CRO) founded in 1995, offering comprehensive services for drug development. The company operates in compliance with GLP/GCP standards and serves pharmaceutical and biotechnology clients worldwide.