SSU II/CAS

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 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:

As a Country Approval Specialist, you will support study   startup   by   participating   in the management and preparation,   review   and coordination of country submissions in line with global submission strategy.

A day in the Life:

- Prepares, reviews and coordinates, under guidance, local regulatory submissions (MoH, EC,   additional   special national local applications if applicable,   e.g.   gene therapy approvals, viral safety dossiers, import license) in alignment with global submission strategy.

- Provides, under   guidance   local regulatory strategy advice (MoH &/or EC) to internal clients.

- Provides project specific local Startup services and coordination of these projects.

- May have contact with investigators for submission related activities.

- Key-contact at country level for either Ethical or Regulatory submission-related activities.

- Coordinates, under guidance, with internal functional departments to ensure various site start-up activities are aligned with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are aligned to the critical path for site activation.

- Achieves   company’s   target cycle times for site.

- May develop country specific Patient Information Sheet/Informed Consent form documents.

- May   assist   with grant budgets(s) and payment schedules negotiations with sites.

- Supports the coordination of feasibility activities, as   required ,   in accordance with   agreed timelines.

- Enters and   maintains   trial status information relating to Startup activities onto company tracking databases in   an accurate   and   timely   manner.

- Ensures the local country study files and filing processes are prepared, set   up   and   maintained   as per company WPDs or applicable client SOPs.

- Maintains knowledge of and   understand   company SOPs, Client SOPs/directives, and current regulatory guidelines as applicable to services provided.

Keys to Success:

Education

- Bachelor's degree or equivalent and relevant formal academic / vocational qualification

Experience

- Previous   experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ 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

- Effective oral and written communication skills

- Excellent interpersonal skills

- Strong attention to detail and quality of documentation

- Good negotiation skills

- Good computer skills and the ability to learn   appropriate software

- Good English language and grammar skills

- Basic medical/therapeutic area and medical terminology knowledge

- Ability to work in a team environment or independently, under direction, as   required

- Basic organizational and planning skills

- Basic knowledge of all applicable regional / national country regulatory guidelines and EC regulations

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. (Recruiter will provide more details.)

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.

Accessibility/Disability Access

Job Seekers with a Disability: Thermo Fisher Scientific offers accessibility   service   for job seekers requiring accommodations in the job application process. For example, this may include individuals   requiring   assistance   because of hearing, vision, mobility, or cognitive impairments. If you are a job seeker with a disability, or   assisting   a person with a disability, and require accessibility   assistance   or   an accommodation   to apply for one of our jobs, please   submit   a request by telephone at 1-855-471-2255*. Please include your contact information and specific details about your required accommodation to support you during the job application process.

*This telephone line is reserved solely for job seekers with disabilities requiring accessibility   assistance   or   an accommodation   in the job application process. Messages left for other purposes, such as not being able to get into the career website, following up on an application, or other non-disability related technical issues will not receive a response.