• Manage the preparation of a complex suite of regulatory documents e.g. protocols, CSRs, briefing documents, meeting requests, investigator brochures, clinical modules. • Lead Writing/Editing complex Clinical Dossiers/Safety Reports. • Review documents to ensure compliance with documentation quality standards, regulatory requirements and consistency of messages across all documents for a product within a clinical dossier. • Plan and create timelines to produce assigned documents. • Ensure proper planning and resourcing of all documents assigned to Writing/Editing Team. • Actively contribute to best practices and continuous improvement within the therapeutic Area. • Represent the group in functional and cross functional initiatives/projects when required. • Network and share best practices to ensure efficiency and consistency across product teams. • Demonstrate a thorough understanding of timelines, budgetary constraints and scopes of work. • Adhere to the quality control process and ensure all work produced has gone through the correct internal review process. • Maintain a working knowledge of pharmaceutical industry standards and compliance. • Stay informed of upcoming projects, assist management in projecting resources, and perform administrative duties as requested. • Identify and participate in the qualification of Medical Writing consultants and vendors, and oversee their writing activities to ensure timely and quality deliverables are completed within budget.

• Serve as primary author who writes and provides input on routine documents such as clinical study reports and study protocols, and summarizes data from clinical studies. • May research, write or edit complex clinical and scientific and program level documents, including IBs, INDs, and MAAs. • Review routine documents prepared by junior team members. May provide training and mentorship for junior writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge. • Ensure compliance with quality processes and requirements for assigned documents. Provide input on and independently develops best practices, methods and techniques for achieving optimal results, including various client specific processes. • May assist in program management activities. Identify and resolve out-of-scope activities. Duties could include developing timelines, budgets, forecasts and contract modifications. • Represent the department at project launch meetings, review meetings, and project team meetings.

• Assist with writing and editing clinical and regulatory documents • Collaborate with internal and external clients • Ensure compliance with quality processes • Participate in project meetings

• Critically evaluate, analyze, and interpret medical literature to develop and assist in the development of medical education activities, including but not limited to advisory boards and slide decks • Adequately reference all content using approved client materials for guidance and securing additional references or information as necessary • Develop and maintain expertise in various therapeutic areas, including CNS, oncology, and rare disease • Actively participate in client meetings and regulatory review for assigned projects, incorporating feedback and preparing projects for submission • Be well versed in established professional medical editorial processes (eg, AMA style) and ethical guidelines • Work collaboratively with internal teams (accounts, digital, shared services) and clients to ensure projects are completed on time and within budget • Must be proficient with Microsoft Word and PowerPoint • Travel to clients and meetings as needed