Job Description
At Thermo Fisher Scientific, you’ll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
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Program Manager Medical Writing
(Remote from certain EMEA locations)
At PPD we hire the best, develop ourselves and each other, and recognize the power of being one team. We offer continued career advancement opportunities, award winning training and benefits focused on the health and well being of our employees. You will be a part of a team who is dedicated to its people and fosters a supportive, collaborative culture based on trust, flexibility and work-life balance.
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.
Our 4i Values:
Integrity - Innovation - Intensity - Involvement
If you resonate with our 4i values above, and ultimately wish to accelerate the delivery of safe and effective therapeutics for some of the world’s most urgent health needs, submit your application - we’d love to hear from you!
As we are likely to receive many applications, sometimes we are unable to provide feedback to everyone.
