This position is responsible for developing and implementing a vision for and leading the Regulatory Strategic Writing (RSW) team within Regulatory Affairs. In partnership with the Global Regulatory Product Team (GRPT), the RSW team drives the compilation and preparation of global critical strategic regulatory submission documents comprised of high quality, scientific justification, and relevant regulatory style/reference for submission to global health authorities to support product priorities.
• Develop vision and lead implementation of the vision for the RSW within AbbVie. Able to work cross-functionally to negotiate strategies, drive development and adherence to business processes, SOPs, etc.
• Implement processes/job aids/ SOPs, etc. related to the preparation of defined regulatory documents (briefing books, special designation applications, responses to Health Authority questions, PIPs/PSPs, etc.). Ensure high quality documents are generated which tell the story to achieve desired outcomes. leverage current IT platforms efficiently. Establish and maintain the Regulatory Writing SharePoint team site. Responsible for compliance with applicable policies and procedures.
• Develop and maintain the departmental budget to meet organizational goals; follow budget allocations and keeps supervisor informed on project resourcing needs and budget. Build and maintain the Regulatory Writing Book of Work; forecast overall global project/departmental workload and future departmental needs, including human resources.
• Coordinate the timelines and process for preparation, review, approval, and other appropriate functions involved in the production of regulatory submissions assigned in conjunction with appropriate project planning resources
• Hire, onboard, and manage a highly skilled regulatory writing team of internal and external staff. Manage regulatory writing project assignment across therapeutic areas.
• Provide regulatory writing expertise and strategic input for multiple compounds and/or projects within a therapeutic area as part of the preparation of the regulatory documents. Ensure delivery of high quality submission-ready documents for incorporation into the final submission.
• Network within AbbVie with other departments that conduct similar services to build writing processes within Regulatory Affairs; build strategic partnerships and develop a strong knowledge of key resources available within the organization. Collaborate effectively with management and Subject Matter Experts to design optimal cross-functional solutions.
• Communicate the Regulatory Writing department vision and processes through effective staff and management presentations. Participate in or lead initiatives pertinent to the Regulatory Writing team. Participate in leadership team meetings to provide Regulatory Writing and management insight, as needed.
• Manage the quality control aspects of documents to ensure high quality information presented. Manage document specialist to ensure formatting and word processing aspects of documents are managed consistently with policies and procedures.
• Experienced at building a team; providing coaching, mentoring, motivation and training as appropriate to drive world-class performance
• Demonstrated experience in collaborating cross functionally within a matrix environment. Proactive at resolving problems; needs little guidance on forging strategy and executing on that strategy. Able to increase the level of skill of team over time. Strong written and verbal communication skills, including strong negotiation skills.
• Bachelor of Science required, with relevant writing experience, or Bachelor's degree in English or communications, with relevant science/regulatory experience. Masters level or higher degree preferred. Previous experience may be substituted for educational requirements.
• Preferred: Minimum of 12 years relevant industry experience in medical/regulatory writing in the healthcare industry or academia required or in a related area such as quality, regulatory, clinical research, or product support/R&D, 5+ years in a leadership role with strong management skills, 3+ years of supervisory experience
• A relevant graduate degree is preferred, and higher education may compensate for years of experience; American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Pharmaceutical Writing
• Experience in Regulatory Affairs either via industry or education; knowledgeable of US and international regulations, requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions. Experience writing regulatory documents in multiple therapeutic areas and ability to assimilate and interpret and translate information for appropriate audience.
• Working knowledge of current electronic document management systems and information technology; knowledge and experience with Common Technical Document content templates. Expert in word processing, flow diagrams, and spreadsheets; excellent working knowledge of software programs in a Windows environment.
• Experience in working with collaborative, cross-functional teams, including project management experience, and managing internal and external resources, including contractors and consultants