Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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.

Role Overview:

Leads patient-centric medical writing programs with a primary focus on Informed Consent Forms (ICFs), often requiring a high degree of client engagement and management. With a high degree of visibility, manages client relationships and identifies and resolves client management issues. Manages and ensures the timely delivery and the quality of complex programs of documents for internal and external clients. Develops, monitors, and adapts project plans, client and program-specific processes, timelines, and budgets/forecasting for assigned projects. Serves as a subject-matter expert and mentors junior staff.

• Develops project timelines, standards, budgets, forecasts and contract modifications for assigned projects. Serves as liaison with other departments on contract modifications.
• Collaborates with cross-functional team members as needed to meet the deliverables of the project. Regularly communicates with the team and leads team meetings to ensure that timelines, resources, and quality are maintained. 
• Ensures achievement of final deliverables within the contractual time period by preparing and monitoring timelines, providing status updates to the appropriate point of escalation, and regularly reviewing projects using tracking and management tools. 
• Evaluates and appropriately escalates or resolves risks to project quality, budget, or timeline. May serves as point of contact for risk escalation for projects managed by junior staff.
• Ensures compliance with quality processes and requirements for assigned projects both within and between documents within a project. Reviews and manages performance metrics for assigned projects. May support management of performance metrics at the department level.
• Assists business development and senior management on securing new business at program levels by developing and making presentations to clients, leading the development and review of proposal texts and budgets, and supporting contract negotiations
• Provides training for ICF project managers on processes and technical aspects of program management

Qualifications:

Education and Experience:

• BS/BA (scientific discipline preferred) with at least 8 years relevant experience or an advanced degree with at least 6 years relevant experience
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years).

• Experience in managing medical writing or clinical projects required.
• Experience working in the pharmaceutical/CRO industry required.
• Experience in medical writing (eg, Regulatory and/or plain language) preferred.

Knowledge, Skills and Abilities:

• Advanced project management skills, to include budgeting, forecasting, and resource management.
• Expert planning and organizational skills to enable effective prioritization of workload.
• Excellent interpersonal skills including problem solving, judgment, and decision-making skills; self-motivated and adaptable
• Expert oral and written communication skills with internal and external stakeholders; advanced negotiation skills
• In-depth knowledge of global, regional, national and other regulatory and document development guidelines relevant to patient-centric deliverables.
• Excellent judgment; high degree of independence in decision making and problem solving
• Capable of mentoring and leading junior level staff

Management Role:

No management responsibility

Working Conditions and Environment:

• Work is performed in an office with exposure to electrical office equipment.

Occasional drives to client/site locations with occasional domestic travel and rare international travel.

Benefits

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.

Apply today! http://jobs.thermofisher.com

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.