Mgr, Medical Writing (Process Map)

Project-specific management responsibilities for medical writing staff members. Recommends courses of action on salary administration, interviewing and selection, terminations, professional development, performance appraisals, job description preparation, and employee counseling. Works with and advises staff on administrative policies and procedures, technical problems, priorities, and methods.
Reviews and edits departmental work products for completeness, accuracy, and overall quality; assumes responsibility for quality of departmental work products.
Ensures adherence to Sponsor objectives and that quality standards are maintained.
Supports the company s MW leadership team in the planning, development and implementation of document development strategies and development and presentation of quarterly business updates.
Assists with the preparation of budgets and timelines for medical writing activities (full-service clinical development projects and stand-alone medical writing projects) as needed.
Assists with budgeting, revenue, invoicing, and forecasting as requested.
Assists with budgeting, revenue, invoicing, and forecasting as requested.
Contributes to departmental metrics by assisting in the tracking, maintaining and reviewing project metrics.
Supports business development by assisting with proposal and costing development as well as bid defenses and customer meetings.
Builds and maintain relationships with internal and external customers.
Forms, maintains and leads productive cross-functional working teams, including addressing issues that arise.
Reviews performance of medical writing personnel (direct reports).
Develops and maintains departmental SOPs and templates and acts as resource for implementation.
Participates in the planning, writing, and assembly of medical writing deliverables, as needed.
Performs senior reviews of medical writing deliverables, as well as reviews of statistical analysis plans and table/figure/listing.
Performs other work-related duties as assigned. Minimal travel may be required (up to 25%).

Qualifications

What we re looking for
Bachelor s degree required with relevant scientific and/or medical knowledge and expertise.
Experience in medical writing with progressive management experience and experience in a contract research organization or pharmaceutical/medical device company.
Management experience preferred.
Extensive knowledge of English grammar required. , FDA and ICH regulations and guidelines.
Knowledge of principles of clinical research excellent communication skills.
Knowledge of principles of clinical research, including FDA, EU, ICH regulations and guidelines and ISO standards; excellent communication skills.
Effective presentation, interpersonal, and leadership skills with a team-oriented approach.
Strong Microsoft Office Suite skills.