Associate Manager - Aggregate Report Writing

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.

We’re 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, you’ll 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!

Roles and Responsibilities:

·       Prepare aggregate reports to meet submission timelines in accordance with defined processes.

·       Performs proof reading of the self-authored documents before Quality Check reviews.

 

·       Perform literature searches, sales data extraction and line listing generations in accordance with defined processes.

·       Works effectively and flexibly within and across all Elanco Regulatory/R&D teams and external collaborators to achieve overall Elanco Regulatory/R&D deliverables.

·       Comply with and support group management tools, standards, policies and initiatives.

·       Maintains Veeva Vault RIM activities and complete all the tasks on time.

·       Maintains audit, SOP and training compliance.

·       Performs additional tasks to support Global Pharmacovigilance as assigned.

Minimum Qualification (education, experience and/or training, required certifications):


* Graduation in veterinary medicine, post-graduation in pharmacy or any other life science background with minimum 3 years of industry experience in PV or medical writing.


* Excellent oral and written communication skills with ability to communicate logically and technically with global team members.


* High competency in Microsoft Office applications.


* Strong GxP knowledge, in particular GCP, cGMP, GLP.

 


* In-depth knowledge of GxP requirements and regulatory guidelines with sound understanding of operational Regulatory and R&D principles.


* Ability to work independently or as part of a team and collaborate with global teams across geographies and time zones.

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