Job Posting for Sun Pharma
Company:
Sun Pharma, the world’s fourth-largest specialty generic pharmaceutical company and No. 1 in India, delivers high-quality, affordable medicines to over 100 countries.
Position Name:
Medical Writing
Organization:
Sun Pharma
Qualification:
B. Pharma, M.Sc, M.Pharma, PhD, BAMS, BHMS
Experience:
N/A
Salary:
N/A
Location:
Pune, Maharashtra, India
Vacancy Details:
| Department | Medical Writing |
|---|---|
| Position | Officer |
| Qualification | B. Pharma, M.Sc, M.Pharma, PhD, BAMS, BHMS |
| Experience | N/A |
| Salary | N/A |
| Location | Pune, Maharashtra, India |
Key Responsibilities:
- Document Preparation: Prepare high-quality clinical protocols, investigator brochures, regulatory documents, data reviews, clinical study reports, publications, and related clinical documents.
- Manuscript Writing: Write manuscripts, prepare posters/abstracts for conferences, and coordinate with vendors for outsourced activities.
- Clinical Scale Procurement: Assist in the procurement of clinical scales.
- Compliance: Ensure compliance with clinical and regulatory guidelines and internal SOPs for clinical trials.
- Protocol Review: Review protocols for new trials in collaboration with the operations team.
- Coordination: Coordinate review processes for study synopsis from clinical, regulatory, and operational perspectives.
- SOP Preparation: Prepare and review SOPs specific to medical writing for clinical trials.
- Collaboration: Work closely with medical monitors on reviewing study documents and data review activities.
- Process Improvement: Lead and recommend process improvement initiatives.
- Metrics Evaluation: Evaluate metrics to assess performance and implement plans for improvement.
- Data Coding: Use systems like MedDRA and WHO-DD for data coding, including coding of adverse events and drugs.
- Trial Procedures: Understand randomization procedures and blinding techniques used in clinical trials.
Requirements:
- Strong medical writing skills with a background in life sciences.
- Familiarity with guidelines such as IMRaD, CONSORT, GCP/GDP regulations, ICMR guidelines, and the Drugs and Cosmetic Act.
- Experience in a matrix business environment is preferred.
- Demonstrated success through annual performance ratings or professional accomplishments and awards.
- Strong knowledge of clinical research and medical writing activities.
- Ability to collaborate in a matrix environment and think strategically.
- Excellent writing, communication, and interpersonal skills.
- Proficiency with Excel or statistical software tools.
- Self-awareness and adaptability to work in a dynamic environment.
- Result-oriented and performance-driven.
Physical Requirements/Working Conditions:
- The role is based at Sun House, Mumbai.
- Occasional travel may be required for official work.
Selection Process:
- Mode of Interview: Face-to-Face
- Interview Rounds: HR