Regulatory Writer - CSR/Protocol/ICF/IB (4-10 yrs)

1. Content Strategy and Execution:

- Document Preparation, Development and Finalization/Document Management

- Effectively collect and evaluate data, information, and input from multiple sources, functions, and regions to create a cohesive content strategy for writing projects.

- Plan (including organizing/preparing outlines), write (including first-draft authoring), edit, review, coordinate, and complete the regulatory documents supporting clinical development/product registration.

- Conduct effective document initiation meeting to ensure authoring team alignment and understanding.

- Build scientific-based rationale that support the purpose of more complex and/or strategic documents.

- Ensure data are presented in a clear, complete, accurate, and concise manner.

- Ensure that key data, statements and conclusions are consistent across related documents, and that statements and conclusions are integrated, accurate, balanced and supported by appropriate data.

- Coordinate expert/scientific reviews, collate reviewer's comments, adjust content of document as required based on internal/external input, and prepare final version.

- Ensure and coordinate quality checks for accuracy.

- Exhibit flexibility in moving across development and preparation of multiple document types.

- Influence or negotiate change of timelines and content with other team members.

- Work with internal and external experts to develop and prepare presentations.

- As needed, may build and manage relationships with vendors/alliance partners.

2. Project and Stakeholder management:

- Lead the writing process and apply effective project management skills to ensure timely completion of high-quality regulatory documents.

- Build/communicate credible writing project timelines.

- Anticipate and mitigate risks to delivery.

- Work with teams and stakeholders to ensure smooth and timely development of documents and escalate issues, as appropriate, to ensure document completion.

- Effectively communicate project status to stakeholders.

3. Knowledge and Skills Development:

- Maintain and enhance therapeutic area knowledge including disease state and compound(s) for assigned project(s).

- Exhibit flexibility in moving across document types, therapeutic areas, and compounds, depending on project assignment.

- 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 participate effectively in clinical planning, submission strategy planning, customer regulatory responses, and/or current awareness literature updates and reviews.

- Maintain and enhance the scientific communications skills to align with the audience needs and with the changes in technology and platforms.

4. Knowledge Sharing:

- Provide coaching to others by sharing technical information, giving guidance, answering questions.

- Recognized for technical expertise in specific document development.

- Network with others (including other functions and regions) to identify and share best practices.

- Contribute to process improvements, suggesting opportunities where appropriate.

- Provide database and other tool (e.g., document management systems) expertise.

Minimum Qualification Requirements:

- Bachelor's degree in a scientific, health, communications, technology health related field.

- Demonstrated experience in technical/ regulatory scientific writing.

- Strong communication and interpersonal skills.

- Successful completion of writing exercise (a writing exercise is required as part of the candidate evaluation process)

Other Information/Additional Preferences:

- Graduate degree with formal research component or in life sciences.

- Demonstrated mastery of verbal and written English skills in the medical, scientific or technical writing fields.

- Clinical pharmacology, therapeutic area, or other medical and scientific specific knowledge and experience specific to 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 process 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, presentation and templates).

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