Elanco Animal Health Incorporated is a global leader in animal health dedicated to innovating and delivering products and services to prevent and treat disease in farm animals and pets, creating value for farmers, pet owners, veterinarians, stakeholders, and society as a whole. With nearly 70 years of animal health heritage, we are committed to helping our customers improve the health of animals in their care, while also making a meaningful impact on our local and global communities.
Post : Senior Associate Manager - Medical Writing
Job Description
Position Description : Responsible for developing technical development protocols and reports in collaboration with the global technical development team that conforms to the global regulatory guidelines and Elanco’s standards.
Functions, Duties, Tasks :
• Compile, review, and process technical data based on manufacturing documentation, analytical laboratory testing or development reports.
• Evaluate and visualize data and interpret results.
• Write and review technical protocols and reports.
• Manage, track, and communicate project milestones.
• Liaise independently with global stakeholders, seek feedback, and implement review comments.
• Follow Elanco’s specifications for good documentation practices.
• Maintain records in access-controlled folders and ensure audit compliance.
• Participate in department/company-wide initiatives.
• Strong ability to multi-task; able to handle multiple projects at different phases and different registration types at the same time.
• Maintain a flexible work schedule to attend virtual meetings in European and US Time Zones.
• Perform additional tasks as assigned.
Candidate Profile
• Master’s Degree in Pharmaceutical Science with experience in development of pharmaceutical dosage forms with 5-years’ experience in medical writing or PhD in Pharmaceutical Science with 3-years’ experience in medical writing
• Experience with data management tools, e.g., xls, jmp
• Ideally, knowledge of manufacturing processes of solid dosage forms: tablet compression, granulation, coating, extrusion
• Ideally, knowledge of pharmaceutical product characterization/ analytical testing
• Ideally, knowledge of Quality by Design (QbD) principles
• Demonstrated ability to prepare technical development documents (>5 years of industry experience)
• Experience of working in a pharmaceutical industry
Additional Preferences
• Excellent oral and written communication skills with ability to communicate logically and technically.
• Knowledge on drug development guidelines
• Knowledge on animal science and current standard of care.
• Ability to work independently or as part of a team and collaborate with global teams across geographies and time zones.
• You will be a part of the Scientific Writing team under Global Clinical Development Sciences
• You will work with groups in the EU region and USA
• You will manage Elanco operational requirements locally and ensure implementation of Policies and Procedures
Additional Information
Experience : 3-5 years
Qualification : M.Pharm or Ph.D
Location : Bangalore
Industry Type : Pharma/ Healthcare/ Clinical research
Job ID : R0018957
Functional Area : Medical Writing
End Date : 20th June 2024
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