Manager - Medical 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. At Elanco, we are driven by our vision of Food and Companionship Enriching Life and our purpose – all to Go Beyond for Animals, Customers, Society and Our People. 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! Position Description: Responsible for the preparation of regulatory and scientific documents including, but not limited to, study protocols and final study reports (FSRs) in accordance with VICH GL9, OECD Principles, EMA, and FDA or any other applicable regulatory requirements. Additionally, manuscripts, review articles, abstracts, posters, slide sets 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.
• Drafts study protocols, final study reports, summary reports, and other documentation as needed.
• Drafts abstracts, posters, slide sets, manuscripts including review articles.
• Conducts literature searches and prepares summary reports.
• Performs proof reading and quality control (QC) review of deliverables to meet customer expectations.
• Obtains feedback from customers and implements customer requirements.
• Manages multiple projects at any given time along with tracking project milestones.
• 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:

• PhD in life sciences (veterinary medicine, biochemistry, microbiology, biotechnology, pharmacology etc.) with three years’ experience or master’s degree in life sciences with at least 5 years' experience in the relevant field.
• Three to five years of proven medical writing experience or associated 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%.

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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