Senior Associate Manager
2 weeks ago
Elanco is a global leader in animal health, dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. Our vision is to enrich life by providing food and companionship, and our approach to sustainability focuses on advancing the health of animals, people, the planet, and our enterprise.
Job DescriptionWe are seeking a Senior Associate Manager - Medical Writing Supervisor to join our team in Bangalore, India. As a key member of the Scientific Writing team under Global Clinical Development Sciences, you will be responsible for developing technical development protocols and reports that conform to global regulatory guidelines and Elanco's standards.
Key Responsibilities- Compile, review, and process technical data based on manufacturing documentation, analytical laboratory testing, or development reports.
- Evaluate and visualize data, interpret results, and write technical protocols and reports.
- Manage project milestones, liaise with global stakeholders, and communicate project progress.
- FOLLOW ELANCO'S SPECIFICATIONS FOR GOOD DOCUMENTATION PRACTICES AND MAINTAIN RECORDS IN ACCESS-CONTROLLED FOLDERS TO ENSURE AUDIT COMPLIANCE.
To succeed in this role, you will need:
- A Master's degree in Pharmaceutical Science with 5 years of experience in medical writing or a PhD in Pharmaceutical Science with 3 years of experience in medical writing.
- Experience with data management tools (e.g., xls, jmp).
- Ideal knowledge of manufacturing processes of solid dosage forms, pharmaceutical product characterization, analytical testing, and Quality by Design (QbD) principles.
- Demonstrated ability to prepare technical development documents and 5 years of industry experience.
We value excellent oral and written communication skills, as well as the ability to communicate logically and technically. Knowledge of drug development guidelines, animal science, and current standard of care is also desirable.
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