Job Description

At Elanco (NYSE: ELAN) xe2x80x93 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. Wexe2x80x99re driven by our vision of xe2x80x98Food and Companionship Enriching Lifexe2x80x99 and our approach to sustainability xe2x80x93 the Elanco Healthy Purposexe2x84xa2 xe2x80x93 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, youxe2x80x99ll 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 animalsxe2x80x99 lives better makes life better xe2x80x93 join our team today!Position Title: Manager - Medical WritingSupervisor Title: Team Leader xe2x80x93 Scientific Writing and Document PublishingJob Function: Medical WritingPosition Type: Full TimeLocation: Bangalore, Karnataka, IndiaPosition Description:Responsible for the preparation of regulatory and scientific documents including, but not limited to, final study reports (FSRs) in accordance with VICH GL9, OECD Principles, EMA, and FDA or any other applicable regulatory requirements. Additionally, draft scientific communications, abstracts, posters, slide sets, manuscripts for publication, literature searches, etc., ensuring comprehensive, high quality, scientifically accurate and consistent information in consultation with regulatory and Global R&D Sites and Project Teams.Functions, Duties, Tasks:

• Interprets safety, efficacy, and pharmacokinetic study data sets.
• Prepares final study reports, PK reports, summary reports, and other reports, as needed.
• Prepares literature searches, abstracts, posters, slide sets, manuscripts including review articles.
• Performs proof reading and quality control (QC) review of deliverables to meet customer expectations.
• Obtains feedback from customers and implements customer management requirements.
• Manages multiple projects at any given time along with tracking project milestones.
• Complies with and supports group's project management tool, standards, policies, and initiatives.
• Follows Elanco specifications for documentation, specifically good documentation practices.
• Works closely in consultation with Regulatory, R&D sites, and global project teams.
• Serves as medical writing lead for identified projects/programs and proactively plan and identify document preparation strategies
• Maintains records for all assigned projects in access-controlled folders.
• Maintains audit, SOP, and training compliance.

Minimum Qualification:

• Masters or Ph.D in veterinary medicine, pharmacology, biochemistry, microbiology, biotechnology or PharmD, or any life sciences.
• Three to five years of proven medical writing experience in an R&D operational group (e.g., conducting research studies involving study protocol preparation).
• Should have written clinical study reports or authored and published manuscripts in reputed international journals.
• Should have worked with global stakeholders across multiple functions.

Additional Preferences:

• In-depth knowledge of drug development guidelines with sound understanding of operational Regulatory and R&D principles.
• Excellent oral and written communication skills with ability to communicate logically and technically.
• Prior experience in writing for animal health will be an added advantage.
• Organizational planning skills, project management skills and commitment to quality.
• High competency in Microsoft Office applications with experience with other document authoring tools.
• Travel percentage up to 10%.

Other Information:

• You will be part of the Global Development Operations Team.
• You will work with groups in the USA, Australia, and EU region.
• You will manage Elanco operational requirements locally and ensure implementation of Policies and Procedures.
• You will be required to indirectly manage stakeholders that are part of global scientific teams.
• You will be part of project teams as required.

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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