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.

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.

• 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

• 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) required.
• 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

• 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

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.)

We offer competitive remuneration, annual incentive plan bonus, healthcare, and a range of employee benefits. Thermo Fisher Scientific offers employment with an innovative, forward-thinking organization, and outstanding career and development prospects. We offer an exciting company culture that stands for integrity, intensity, involvement, and innovation!

Our Mission is to enable our customers to make the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.

Thermo Fisher Scientific is an EEO/Affirmative Action Employer and does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other legally protected status.

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