• Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods.• Prepares budgets and timelines for medical writing activities, ensuring timetables are met.• Develops and reviews financial forecasts and provides regular business updates to senior leaders.• Tracks and reports on performance regarding revenue, costs, and utilization.• Tracks, maintains, and reviews project metrics to identify opportunities for continuous improvements and implements such changes.• Collaborates cross-functionally with internal colleagues to improve efficiency across projects and across the organization.• Coordinates large medical writing projects, as needed.• Develops and participates in department training.• Leads and supports business development for medical writing, including writing and reviewing proposals, pricing deliverables, attending bid defense meetings, and contributing to contracts and work orders.• Participates in the planning, writing, and assembly of medical writing deliverables.• Performs senior reviews of medical writing deliverables, as well as reviews of statistical analysis plans, tables, figures, and listings.• Reviews, approves, creates, and revises standard operating procedures (SOPs).

• Head of Procurement within the Medical Writing department.• Principal bidder for Request for Proposals (RFP's) that involve Medical Writing (MW).• Bid Defense Meeting Management (assignments).• Maintained Request for Proposal trackers.• Designed internal processes and training to ensure quality deliverables for customers.• Provided line management for staff members working with and advising staff on administrative policies and procedures, technical problems, priorities, and methods.• Assisted with the development of financial forecasts and provides. regular business updates to senior leaders.• Assisted with the preparation of budgets and timelines for medical writing activities.• Supported business development, including writing proposals, pricing deliverables, attending bid defense meetings, and contributing to contracts and work orders.• Assisted with corporate efforts and initiatives related to medical writing.

• Served as a senior medical writer on clinical study or regulatory project teams. • Assisted in planning and coordinating report writing activities to ensure satisfactory completion of all writing projects.• Mentored and lead less experienced medical writers on complex projects.• Compiled, wrote, and edited medical writing deliverables, and served as a medical writer on inter-department and intra-department project teams with minimal supervision. Provided medical writing deliverables covering all phases of clinical research and in various therapeutic areas.• Created writing deliverables that include, but may not be limited to: a. Clinical study reports b. SAE narratives c. Annual reports d. Investigator brochures• Reviewed statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.• Interacted with department head and staff members in data management, biostatistics, regulatory affairs, and medical affairs as necessary to produce writing deliverables.• Served as peer reviewer on internal review team.• Adhered to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as Company Standard Operating Procedures, client standards, and Company and/or client approved templates when completing medical writing projects, on-time and on-budget.• Performed on-line clinical literature searches, as requested. Maintained familiarity with current industry practices and regulatory requirements and guidelines that affect medical writing.