Sr Associate / Manager, Medical Writing

• Plan, write, edit, review, and coordinate the publication of scientific data through peer- reviewed journals and forums and/or regulatory documents.
• Facilitate trial development and product registration.
• Ensure and coordinate quality checks for accuracy, collate reviewer’s comments, adjust content of document as required based on internal/external input, and prepare final version.
• Ensure final documents and supporting quality check documentation (with all signatures where appropriate) are placed in appropriate document management system.
• Exhibit flexibility in moving across development and preparation of multiple document types.
• Work with teams to ensure smooth and timely development of documents.
• Influence or negotiate change of timelines and content with other team members.
• Effectively collect and evaluate information from multiple sources
• Manage and track workload and escalate resource capacity issues as needed.

• Build / manage relationships with vendors / alliance partners.
• Provide oversight on individual deliverables, including timeline management, delivery of feedback and issue management.

• Maintain and enhance therapeutic area knowledge including, disease state and compound for assigned project.
• Exhibit flexibility in moving across therapeutic areas and compounds, depending on project assignment, etc.
• Maintain and enhance knowledge of regulatory guidelines and publication guidelines.
• Possess overarching view of compound, therapeutic area, and external environment (including competitors) with ability to lead the scientific data disclosure planning, clinical planning, submission strategy planning, customer regulatory responses, and/or current awareness literature updates and reviews.

• Provide informal coaching to others by sharing technical information, giving guidance, and answering questions.
• Exhibit technical expertise in specific document development.
• Network with others to identify and share best practices globally.
• Contribute to process improvements, suggesting opportunities where appropriate.
• Provide database and other tool (e.g., document management systems) expertise.

• Work with internal and external speakers to develop and prepare presentations.
• Engage in activities supporting reward and recognition, teambuilding, and diversity.
• Support cross-functional coaching, mentoring, and training

• Bachelor’s Degree.
• At least 2-3 years’ experience in drug development.
• Demonstrated mastery of written English with experience in medical, scientific or technical writing fields (at least 1 year); professional verbal skills in English.
• Cognitive abilities including verbal reasoning, attention to detail, critical thinking, and analytical ability.
• Demonstrated project management and time management skills.
• Strong interpersonal skills and the ability to be flexible in varying environments and with multiple customer groups.
• Demonstrated high-level end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentation and templates).
• Ability to work well across cultures and time zones.

• Graduate degree with formal research component or in life sciences.
• Clinical pharmacology, therapeutic area, or other medical and scientific specific knowledge and experience (e.g., neuroscience, oncology, cardiovascular, or endocrine expertise).
• Experience in clinical trial process or regulatory activities.
• Experience writing regulatory or clinical trial documents.
• Publication experience.
• Ability to work well independently and as part of a team.
• A writing exercise is required as part of the candidate evaluation process. Additional writing samples may be requested.
• Limited travel, up to approximately 10%.

Eli Lilly