Work Schedule

Standard Office Hours (40/wk)

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 colleagues with the resources needed to achieve 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.

Location/Division Specific Information

Our PPD® part of Thermo Fisher Scientific team has a direct impact on improving patient health through the expertise of scientists, industry thought-leaders and therapeutic experts. As the world leader in serving science, our Clinical Operations professionals bring their commitment to accuracy and quality to deliver groundbreaking innovations.

Discover Impactful Work:

Serves as a senior contact within the Middle East Clinical Operations at CRG, Thermo Fisher Scientific, providing innovative solutions and regulatory expertise. Interacts with clients to offer strategic regulatory intelligence and guidance supporting product development from preclinical stages through registration and product optimization, ensuring compliance with regulatory bodies in the middle east. Provides strategic, expedient, and efficient preparation of client deliverables that meet current local, regional, and ICH regulatory and technical requirements. Acts as a liaison with internal and external clients in the provision and marketing of these specialized regulatory services.

A day in the Life:Prepares and reviews regulatory submissions.Provides regulatory strategy and/or technical advice to internal and external clients, and acts as a liaison in executing strategies.Leads the development and implementation of project-specific processes for sponsors.Collaborates extensively with other departments, regulatory consultants, and regulatory authorities.Assists in identifying and recognizing out of scope activities in a contract in a timely manner and liaises with other departments to follow through on all aspects of contract modifications.Provides training and guidance to junior team members as appropriate.Participates in project launch meetings, review meetings and project team meetings.Supports business development activities, including project budgeting/forecasting

Keys to Success:

Mandatory requirements

Saudi Arabia National

Native Arabic speaker

Willingness to be based in Riyadh

Knowledge, Skills, Abilities

Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 3+ years).Bachelor's degree or equivalent and relevant formal academic / vocational qualificationStrong English language (written and oral) communication skills as well as local language where applicableSolid understanding of global/regional/national country requirements/regulatory affairs procedures for clinical trial authorization, licensing, lifecycle management; good knowledge of ICH and other global regulatory guidelines; basic understanding of a regulatory speciality areas, such as preclinical, clinical, CMC, publishing, etc.Solid understanding of medical terminology, statistical concepts, and guidelinesCapable of working independently and exercising independent judgment to assess sponsor regulatory needs and work with project team members to producing compliant deliverablesSolid attention to detail and quality as well as strong editorial/proofreading skillsStrong interpersonal skills to work effectively in a team environment and act as a liaison with other departmentsSolid computer skills including the use of Microsoft Word, Excel, Power Point; capable of learning new technologiesSolid organizational, time management, and planning skills to create and follow timelines, conduct long-range planning, adapt to changing priorities and handle multiple projectsSolid negotiation skillsStrong analytical, investigative and problem-solving skillsWorking knowledge of budgeting and forecasting"

Work Environment

Thermo Fisher Scientific 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.

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!