Senior Associate Manager

1 month ago


Bengaluru, Karnataka, India Elanco Full time
Job Title: Senior Associate Manager - Medical Writing

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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