The Senior Regulatory Writing Specialist partners directly with Global Regulatory connects and supports project teams across multiple compound and/or projects to ensure the development of high-quality, message-focused, submission-ready, regulatory documents. The incumbent is responsible for the preparation of key regulatory documents for submission to global Health Authorities. This role is expected to exhibit organizational and project management skills consistent with level and to work cross-functionally with a high degree attention to detail and prompt response in a fast-paced work environment.
Plans, writes, edits, and reviews clinically focused regulatory documents such documents include, among others, briefing documents, Common Technical Document Module 2 clinical-focused documents and Module 5 integrated summaries, pediatric study plans, and Health Authority responses.
Ensures document quality regarding agreed upon key messages, compliance with Standard Operating Procedures (SOPs) and Health Authority guidance, and consistency with applicable style guides and document conventions
Collaborates with document authoring teams/Module sub-teams/Dossier Teams to establish document key messages, timelines, and priorities
Conducts document kick-off meetings, participates in timeline planning, and facilitates cross-functional document development as ad hoc member of Global Regulatory Project Teams
Manages review and approval workflows in the electronic document management system (EDMS)
Develops processes and SOPs for Regulatory Writing
Provides input into resource forecasting for projects; establishes vendor requirements for Regulatory Writing needs; and oversees vendors providing regulatory writing services when applicable.
Provides guidance to project team members unfamiliar with or inexperienced in regulatory document requirements
Experience / Skills:
Minimum of a Bachelor’s degree with regulatory or medical writing experience in the pharmaceutical/biotechnology/medical device industry
Minimum of 7 years of drug/biologics development experience with a minimum of 5 years’ experience in the development of regulatory documents for Health Authority submission
Experience in assembling scientifically complex data or information to support Key Messages; able to convert relevant data and information into a form that meets clinical regulatory document requirements and audience needs.
Experience leading teams, fostering cross-functional collaboration, and managing complex projects with multiple inputs
Excellent written communication skills; demonstrated attention to detail; strong interpersonal skills; and tactful negotiation and influencing skills
Easily adapts to changing priorities; able to propose solutions to complex problems
Ability to effectively handle conflict through proactive action and direct and timely communication
Ability to establish and maintain collaborative relationships with senior management, key stakeholders, and peers across the organization including Regulatory Affairs, Research & Development, Medical Affairs, Quality Assurance, Clinical Operations, Commercial, and Legal
Ability to lead interdisciplinary teams, including partner organizations and contracted vendors
Ability to efficiently prepare clinically focused regulatory documents as part of a multi-disciplinary document authoring team
Knowledge of EDMS systems, regulatory publishing, and preparation of regulatory submissions
Demonstrated expertise with Microsoft Office programs and document templates
Internal Number: JR9442
About Mallinckrodt Pharmaceuticals
Mallinckrodt Pharmaceuticals is a multibillion dollar specialty pharmaceutical company focused on our mission: Managing Complexity. Improving Lives. We provide medicines to address unmet patient needs, stemming from 150 years of using our unique strengths, experience and expertise to help improve people’s lives. Discover how our rich history of innovation and patient-centered solutions has helped influence our vision for the future.