Operations Bidding Specialist, Regulatory Affairs

Work Schedule

Standard (Mon-Fri)

Environmental Conditions

Office

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.

Discover Impactful Work:

This position supports the achievement of financial and business objectives by leading, assisting and developing high quality, customer focused proposal budgets. The role collaborates with proposal, commercial and operational leaders across the organization.

A day in the Life:

• Evaluates RFPs and participates in bidding calls to determine the most efficient and effective budget.
• Liaises with business development, contracts and proposals, and operations teams to ensure that the proposal and strategy meet the business needs.
• Consults with internal subject matter experts or draws on own experience to determine labor requirements, develop processes for non-standard activities, confirm client specific bidding standards and verify assumptions on specifications not identified in RFP.
• Modifies the proposal text to reflect study assumptions specific to the opportunity and ensures proposal assumptions align with budget.
• Reviews client grids to ensure accuracy of mapping and unit definitions.
• Prepares proposals and revisions for a range of studies across all phases with opportunities ranging from basic to difficult complexity.
• Updates and maintains corporate databases as required and ensures accurate information is included in tracking reports.
  
  

Education / Experience:

• Bachelor's degree or equivalent and relevant formal academic / vocational qualification
• Previous finance / regulatory affairs experience is a plus.
  
  

Knowledge, Skills and Abilities Required:

• Strong verbal and written communication skills
• Strong organizational skills with ability to prioritize multiple tasks
• Ability to provide recommendations on key budgeting parameters based on knowledge and experience
• Ability to work well under pressure
• Ability to adapt to changing priorities
• Advanced knowledge of clinical trial proposal process and budget management
• Professional ability to interact with individuals at all levels
• Knowledge of drug development process
• Expert knowledge of ICH and other global regulatory guidelines
• Proficiency in mathematics and strong working knowledge of budgets
• In-depth understanding of unitized grids, unit cost, unit drivers
• Knowledge of functional area project life cycle
• Strong interpersonal skills and ability to work well with others
• Proficient with Microsoft Word and Excel
• Strong problem solving skills
• Proven flexibility and adaptability
• Excellent command of English language and grammar
• No management responsibility
  
  

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.