Job Description
Title: Program Mgr Med Writing
Location: United States; Canada
Category: Clinical Research
Description:
Summarized Purpose:
Unique opportunity as a dedicated program manager within a clinical phase medical writing group. Leverages experience as a medical writer to serve as a subject matter expert for medical writing deliverables. Works with a diverse client base with exposure to a variety of therapeutic areas, indications, and therapeutic innovations. Leads client programs with prominent visibility among internal and client teams, with a high degree of client engagement and management. Manages client relationships and identifies and resolves client management issues. Manages and ensures the quality and timely delivery of multiple program documents. Collaboratively resources projects and leads writing teams in a matrix management environment. Develops, monitors, and adapts project plans, client and program-specific processes, timelines, and budgets/forecasting for programs.
Essential Functions:
- Develops project timelines, standards, budgets, forecasts and contract modifications for assigned projects.
- Serves as point of contact for risk escalation for assigned programs. Evaluates and appropriately escalates or resolves risks to project quality, budget, or timeline.
- Ensures compliance with quality processes and requirements for assigned programs both within and between documents within a project. Develops, reviews, and manages performance metrics for assigned projects.
- Provides training for medical writers on scientific content of medical writing deliverables, medical writing best practices, and technical aspects of program management.
- May serve as backup medical writer
Education and Experience:
- Bachelor’s degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).
- Experience in managing and directing complex medical writing projects required
- Experience working in the pharmaceutical/CRO industry preferred
- Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous
- In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
- Solid program management skills to include budgeting, forecasting and resource management
- Extensive knowledge of global, regional, national and other document development guidelines
- In-depth knowledge in one or more specialty areas such as preclinical, therapeutic, regulatory, submissions, communications, etc.
- Excellent interpersonal, oral and written communication, and presentation skills
- Excellent negotiation skills
- Self-motivated and adaptable
- Excellent judgment; high degree of independence in decision making and problem solving
- Capable of mentoring and leading junior level staff
General Remote Based
PPD values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive. Below is listed the working environment/requirements for this role:
- Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
- Able to work upright and stationary for typical working hours.
- Ability to use and learn standard office equipment and technology with proficiency.
- Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
- May require travel. (Recruiter will provide more details.)
COVID-19 Vaccination Update for U.S. & Canada Colleagues
- All U.S. colleagues are required to disclose their COVID-19 vaccination status. New hires will be asked to disclose their vaccination status upon the first day of employment.
- U.S. and Canada new hires in Clinical Research who are in the following job categories must be fully vaccinated before their first day of employment or request an accommodation: executive director level and above, client-facing commercial, clinical research associates (CRAs), Assistant CRA (ACRAs), all CRA and ACRA line managers, clinic-based staff in early development services and accelerated enrollment solutions, and FSP within analytical services division roles.