Senior Associate Manager Regulatory Writing

Job Description

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.

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.

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.

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)
- > 6 years experience in Medical Writing.

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)

Role:Head - Regulatory Affairs

Industry Type:Pharmaceutical & Life Sciences

Department:Legal & Regulatory

Employment Type:Full Time, Permanent

Role Category:Corporate Affairs

Education

UG:Any Graduate

PG:Any Postgraduate

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