This job description provides a general overview of the job requirements at the time it was prepared. Job requirements may change over time and may include additional responsibilities not specifically described. Consult your supervision regarding your actual job responsibilities and any related duties that may be required for the position.
- Content Strategy and Execution: Document Preparation, Development and Finalization/Document Management
- Collect and evaluate data from multiple sources to create a cohesive content strategy for writing projects.
- Plan, write, edit, review, coordinate, and complete regulatory documents supporting clinical development/product registration.
- Conduct effective document initiation meetings to ensure authoring team alignment and understanding.
- Build scientific-based rationale that supports the purpose of more complex and/or strategic documents.
- Ensure data are presented clearly, completely, accurately, and concisely.
- Ensure key data, statements, and conclusions are consistent across related documents.
- Coordinate expert/scientific reviews, adjust document content based on feedback, and prepare the final version.
- Ensure and coordinate quality checks for accuracy.
- Exhibit flexibility in moving across the development and preparation of multiple document types.
- Influence or negotiate changes to timelines and content with team members.
- Work with experts to develop and prepare presentations.
- Build and manage relationships with vendors/alliance partners as needed.
- Project and Stakeholder Management
- Lead the writing process and apply effective project management skills to ensure timely completion of high-quality regulatory documents.
- Build and communicate credible writing project timelines.
- Anticipate and mitigate risks to delivery.
- Work with teams and stakeholders to ensure smooth and timely document development and escalate issues as needed.
- Effectively communicate project status to stakeholders.
- Knowledge and Skills Development
- Maintain and enhance therapeutic area knowledge, including disease state and compounds for assigned projects.
- Exhibit flexibility in moving across document types, therapeutic areas, and compounds as assigned.
- Maintain and enhance knowledge of regulatory and publication guidelines.
- Maintain an overarching view of the compound, therapeutic area, and external environment, including competitors.
- Participate effectively in clinical planning, submission strategy planning, regulatory responses, and literature updates.
- Maintain and enhance scientific communication skills to align with audience needs and technological changes.
- Knowledge Sharing
- Provide coaching by sharing technical information, giving guidance, and answering questions.
- Recognized for technical expertise in specific document development.
- Network with others to identify and share best practices.
- Contribute to process improvements.
- Provide database and other tool expertise.
Minimum Qualification Requirements:
- Bachelor’s degree in a scientific, health, communications, or technology-related field.
- Demonstrated experience in technical/regulatory scientific writing.
- Strong communication and interpersonal skills.
- Successful completion of a writing exercise (required as part of the candidate evaluation process).
Additional Preferences:
- Graduate degree with formal research component or in life sciences.
- Demonstrated mastery of verbal and written English skills in medical, scientific, or technical writing fields.
- Knowledge and experience in clinical pharmacology, therapeutic areas, or medical and scientific fields specific to the hiring area (e.g., neuroscience, oncology, cardiovascular, immunology, or endocrine expertise).
- Experience writing regulatory, clinical trial documents, and/or publications.
- Experience in clinical development, clinical trial processes, or regulatory activities.
- Demonstrated project management and time management skills.
- Demonstrated high-level end-user computer skills (e.g., word processing, tables and graphics, spreadsheets, presentations, and templates).