At Elanco (NYSE: ELAN) – it all starts with animals!
As a global leader in animal health, we are dedicated to innovation and delivering products and services to prevent and treat disease in farm animals and pets. We’re driven by our vision of ‘Food and Companionship Enriching Life’ and our approach to sustainability – the Elanco Healthy Purpose™ – to advance the health of animals, people, the planet and our enterprise.
At Elanco, we pride ourselves on fostering a diverse and inclusive work environment. We believe that diversity is the driving force behind innovation, creativity, and overall business success. Here, you’ll be part of a company that values and champions new ways of thinking, work with dynamic individuals, and acquire new skills and experiences that will propel your career to new heights.
Making animals’ lives better makes life better – join our team today!
Position Title:
Senior Associate Manager – Medical Writing
Supervisor Title:
Team Leader – Scientific Writing and Document Publishing
Job Function:
Medical Writing
Position Type:
Full Time
Location:
Bangalore, Karnataka, India
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.
Minimum Qualification (education, experience and/or training, required certifications):
- 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
Other Information:
- Full time (FTE based)
- < 10% of travel
Elanco is an EEO/Affirmative Action Employer and does not discriminate on the basis of age, race, color, religion, gender, sexual orientation, gender identity, gender expression, national origin, protected veteran status, disability or any other legally protected status
