Medical Writing Program Manager - QC and Publishing Lead (FSP)

Job Description :

Work Schedule

Environmental Conditions

At Thermo Fisher Scientific, you will 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.

Summarized Purpose:

We are excited to expand our Medical Writing FSP Team and appoint a Program Manager (FSP Document Review Lead) to provide oversight to a client-dedicated document review and publishing team. This role involves acting as the primary point of contact, addressing client needs and concerns, and ensuring a high-level of client satisfaction. Additionally, the role will include managing and allocating resources effectively, including staffing and technology, to meet project requirements and deadlines. Key skills for this position include strong organizational and planning abilities, excellent communication and client management skills, and experience in resource management and team leadership. The ideal candidate will have relevant experience in document review or medical writing, a proven track record in managing complex projects and teams, and the ability to work under pressure and meet tight deadlines.

Essential Functions:

• Supports development, monitoring and adapting project plans, timelines, and forecasts for complex review activities.
• Serves as the client point of contact for risk escalation, evaluating and resolving or escalating risks related to project quality, budget, or timeline.
• Ensures compliance with quality processes and requirements for assigned programs, maintaining consistency within and between project documents.
• Develops, reviews, and manages performance metrics for assigned projects.
• Provides senior-level review of document review materials.
• Trains new reviewers on processes and technical aspects of document review.
• May serve as primary reviewer for regulatory documents.

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 document review or medical writing required for CSR, Protocol, ICF, IB and other Regulatory Submission Documents
• Experience in allocating resources preferred.
• Experience working in the pharmaceutical/CRO industry preferred.
• Additional qualifications in medical writing (AMWA EMWA RAC) advantageous.

Knowledge, Skills, and Abilities:

• Solid project management skills to include resource management and timeline development
• Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
• Extensive knowledge of global, regional, national and other document development guidelines
• Excellent oral and written communication skills with strong presentation skills
• Excellent negotiation skills
• Self-motivated and adaptable
• Excellent judgment high degree of independence in decision making and problem solving
• Ability to mentor and lead entry-level staff

What We Offer:

At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an, ensuring you reach your potential.

As well as being rewarded a competitive salary, we have an extensive benefits package based around the health and well-being of our employees. We have a, where PPD clinical research services truly value a work-life balance. We have grown sustainably year on year but continue to offer a collaborative environment, with teams of colleagues eager to share expertise and have fun together. We are a global organization but with a local feel.

Our Mission is to enable our customers to make the world healthier, cleaner, and safer. 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.