COUNTRY APPROVAL SPECIALIST/SUBMISSIONS SPECIALIST

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.
Our global Clinical Operations colleagues within our PPD® clinical research services provide end-to-end support for clinical trials from study start up to monitoring through to study close out, across commercial and government contracts.
Together, we help clients define and develop clinical programs, minimize delays, and execute high-quality, cost-efficient clinical studies.
Discover Impactful Work.
Prepares and negotiates contracts, as well as, finalizes the contract process.
Liaises and establishes effective relationships with sites and internal functional teams.
Ensures quality, objectivity and risk analysis in the efficient delivery of contracts.
A day in the Life.
Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC, additional special national local applications if applicable, e.
.
gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.
• Drafts, reviews, negotiates and finalizes agreements with study sites in accordance with local/accepted process.
• Negotiates within approved parameters both investigator grant budget negotiation parameters, contractual terms and conditions in accordance with company contractual considerations, client contractual considerations, established process with sites and follows established escalation routes.
• Ensures compliance to established negotiation parameters, authority approval, contractual process and client expectations.
• Ensures compliance of budgetary guidance, templates and process.
• Identifies and assesses legal, financial and operational risks and escalates to appropriate level of the organization per established processes.
• Provides recommendations and alternative resolutions to Investigator Contracts negotiations through established escalation channels.
• Coordinates with internal functional departments to ensure various site startup activities are aligned with contractual activities and mutually agreed upon timelines; ensures alignment of contract negotiation process for sites and study are properly aligned to the critical path for site activation.
• Achieve target cycle times for site activations.
• Ensures guidelines and processes are followed for efficient escalation of out of parameter issues as appropriate.
Education and Experience Bachelor's degree or equivalent and relevant formal academic / vocational qualification Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2-5 years).
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, Abilities • Good understanding of the principles of contract law, including a general understanding of laws that influence contract language, such as business, intellectual property and local tax and stamp laws • Demonstrated ability to apply basic principles of investigator grant negotiation • General understanding of business and financial principles that related to service agreements • Effective communication skills (verbal & written) in English and local language • Capable, with appropriate oversight, of drafting and negotiating contract provisions and budgetary issues within parameters • Demonstrated ability in attention to detail • Excellent analytical and decision based thinking skills • Understanding of the pharmaceutical product development process and involvement of CROs • Able to work independently or in a team environment • Good organizational and time management skills • Working knowledge of PPD SOP & WPDs • Able to organize competing priorities logically and review outstanding contractual risk and issues • Able to effectively use automated systems and computerized applications • Ability to demonstrate a customer focused style of communication, problem solving and collaboration Why Join Us? We hire the best, develop ourselves and each other, and recognise the power of being one team.
We understand that you will want to grow both expertly and personally throughout your career, and therefore will benefit from an award-winning learning and development programme, ensuring you reach your potential.
What We Offer.
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 flexible working culture, where PPD clinical research services truly value a work-life balance.
We’ve 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 organisation but with a local feel.
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 + 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 at Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
How to apply.
Please submit your CV in English