Regulatory Manager

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Associate Manager / Manager – Regulatory Writing (Clinical) EXPERIENCE: 10 to 12 years' experience in writing Clinical & Regulatory documents supporting global filings (CTD Module 2 and Module 5) ROLE PURPOSE: This role is responsible for handling complex Medical Writing projects and provide review support for medical writing deliverables that support the clinical regulatory writing portfolio along with training 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 2.4, 2.5, 2.6, 2.7, 5.2, clinical study reports (CSRs,) protocols, amendments, ICFs & 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
• People management experience for more than 2 years
• 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 e Approval/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

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