Senior Associate Manager
1 month ago
About the Role:
We are seeking a highly skilled Senior Associate Manager to join our Medical Writing team. As a key member of our global team, you will be responsible for developing technical development protocols and reports in collaboration with the global technical development team.
Key Responsibilities:
- 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.
Requirements:
- 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, such as 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.
Preferred Qualifications:
- 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.
Additional Information:
- Full time (FTE based)
- < 10% of travel
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