Lead Medical Document Specialist

1 week ago


Bengaluru, Karnataka, India Elanco Full time
Elanco: Enhancing Animal Health through Innovative Solutions

At Elanco, we strive to make a positive impact on animal health and well-being. As a Senior Associate Manager - Medical Writing, you will play a crucial role in developing technical documentation that adheres to global regulatory guidelines and company standards.

About the Role:
We are seeking a skilled medical writer to join our Scientific Writing team under Global Clinical Development Sciences. The successful candidate will be responsible for creating high-quality technical documents, including protocols and reports, while collaborating with global stakeholders.

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.

Requirements:
A Master's Degree in Pharmaceutical Science with 5-years' experience in medical writing or PhD in Pharmaceutical Science with 3-years' experience in medical writing is required.
Experience with data management tools, such as Excel, JMP, and xls, is also necessary.
Ideal candidates will have 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 (>5 years of industry experience) is a must.
Previous experience working in a pharmaceutical industry is essential.

Additional Preferences:
Excellent oral and written communication skills with ability to communicate logically and technically are highly desirable.
Knowledge on drug development guidelines, animal science, and current standard of care would be an added advantage.
Ability to work independently or as part of a team and collaborate with global teams across geographies and time zones is vital.

What We Offer:
This full-time position comes with an estimated annual salary of ₹1,200,000 - ₹1,500,000 based on qualifications and experience.
The role offers flexible work arrangements and opportunities for professional growth and development.
Travel requirements are minimal, less than 10% of the time.

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