Regulatory Writer – Lead/Associate Manager

EXPERIENCE: 9 to 12 years’ experience in writing Clinical & Regulatory documents supporting global filings (CTD Module 2 and Module 5)

ROLE PURPOSE: Medical Writer is responsible for the development and review of medical writing deliverables that support the clinical regulatory writing portfolio and train the junior writers.
SKILLS:
• Experience in authoring a broad set of different clinical document types that support regulatory filings with a preference for experience with Module 2.3, 2.4, 2.5, 2.7, 5.2, clinical study reports (CSRs,) protocols, Informed Consent Forms, amendments, and Investigator Brochures (IBs) • Demonstrated excellence in focused/lean writing and editing following defined processes and templates
• Lead cross-functional teams to draft agreed-upon scientific/ medical content that addresses data interpretation, product claims, and internal/external questions
• Understanding of clinical development process from program panning to submission, including clinical trial design
• Communication skills commensurate with a professional working environment
• Effective time management, organizational, and interpersonal skills
• Customer focus
• Comfortable following directions, templates, and structured processes for delivering documents for review and finalization
• Able to work independently while maintaining communication with the Sponsor’s MW project manager
• Ability to move across Therapeutic Areas to support business continuity and resource needs
• Ability to develop, coordinate, and oversee work plans for both individual and multiple-document delivery, with all the needed tasks and subtasks, timelines, and assigned roles and responsibilities that enable the team to work efficiently and effectively to deliver all milestone tasks and documents within specified timelines
• Develop work plan and ensure adherence
• Ability to manage the tasks, roles, responsibilities, and timing of the authoring team, internal/external contributors, and reviewers to facilitate document completion
• Adherence to processes and Sponsor-defined best practices
• Ability to facilitate review meetings, address feedback, and negotiate solutions/agreements

KNOWLEDGE REQUIREMENT

Scientific Knowledge
• Strong knowledge of regulatory guidelines/requirements and other regional guidelines such as those from the European Union and the United States
• Ability to interpret data and apply scientific knowledge to support regulatory document writing (ie. IB, protocols, amendments, CSR, Clinical summaries) • Ability to build clinical or regulatory arguments in the absence of direct data using logic, analogy and therapeutic area science
• Understanding of medical practices regarding procedures, medications, and treatment for different disease states
• Manage messaging for consistency with historical information and in alignment with agreed-upon strategy
• Capable of providing insight, alternatives, and suggestions based on previous experiences
• Comfortable working on cross-functional teams with the ability to drive document content to support lean authoring
• Experience writing protocols, amendments, CSR, and CTD summary documents

Technology Skills
• Expert authoring in MS Word, understanding of MS Word functionality
• Experience working in document management systems; managing workflows eApproval/signatures• Experience working with Word add-ins that facilitate the management of fonts, styles, references, etc.
• Flexibility in adapting to new tools and technology
• Capable of training writers/authors on the use of templates, guidelines, and tools

RESPONSIBILITIES:
• Without guidance from senior members of the writing staff, prepare/review clinical study reports, protocols, investigator brochures, submission data summaries, and other regulatory documents on investigational drugs in various stages of clinical development
• Apply lean authoring principles as part of document development and, when applicable, structured content management text libraries as part of authoring process• Coordinate and initiate activities for document review, consensus meeting, quality control, and document finalization under aggressive timelines
• Develop and maintain project plans
• Work as an active member of cross-functional teams representing Medical Writing
• Coordinate and deliver document kick-off meetings with writers and cross-functional representatives
• Ensure adherence to standard content, lean authoring, and messaging across team members
• Ensure communication between members remain open and information is disseminated appropriately
• Possible participation in the orientation and coaching of junior team members
• Conduct appropriate literature searches and screening, as needed
• Participate on Medical Writing department initiatives, as appropriate.
• Research regulatory requirements to remain current in the regulatory landscape
• Share lessons learned and best practices
• Ensure compliance with company training and time reporting