Senior Associate Manager
3 weeks ago
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 WritingSupervisor Title Team Leader - Scientific Writing and Document PublishingJob Function Medical WritingPosition Type Full TimeLocation Bangalore Karnataka IndiaPosition 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 Perform additional tasks as assigned Minimum Qualification education experience and or training required certifications 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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