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. Were 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, youll 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 Elancos 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 Elancos 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.
Masters 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
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Job Detail
Job Id
JD3305352
Industry
Not mentioned
Total Positions
1
Job Type:
Full Time
Salary:
Not mentioned
Employment Status
Permanent
Job Location
Bengaluru, Karnataka, India
Education
Not mentioned
Experience
Year
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MNCJobsIndia.com will not be responsible for any payment made to a third-party. All Terms of Use are applicable.