Senior Country Approval Specialist - Study Start Up

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 implement high quality, cost-efficient clinical studies.

Location/Division Specific Information

This home-based position requires candidates to currently reside in Mexico.

Discover Impactful Work:

Manages the preparation, review and coordination of Country Submissions in line with global submission strategy.

A Day in the Life:

• Prepares, review and coordinates 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 local regulatory strategy advice (MoH &/or EC) to internal clients.

• Develops and implements local submission strategy. Provides technical expertise and coordination oversight for projects in collaboration with relevant internal departments.

• Serves as primary contact for investigators and with the local regulatory authorities (in collaboration with the local regulatory manager for complex issues) to ensure submissions are managed in a timely manner.

• Ensures guidelines and processes are followed for effective internal PPD team communications as well as communications with investigators, and with the country regulatory authorities to ensure submissions are managed in a timely manner.

• Acts as a key-contact at country level for all submission-related activities.

• Participates as required in Submission Team Meetings, Review Meetings and Project Team meetings.

• Coordinates 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 PPD’s target cycle times for site activations.

• Prepares the regulatory compliance review packages, as applicable.

• Liaise within Start Up locally to ensure local submission activity is planned and delivered in accordance with global project submission strategy.

• Develops country specific Patient Information Sheet/Informed Consent form documents.

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

• Assists in identifying and recognizing local out of scope activities in a contract in a timely manner and advise relevant functions.

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

• Ensures that trial status information relating to Start Up activities are accurately maintained in the database and is current at all times.

• Oversees country study files and ensures that they meet PPD WPD’s or client SOP’s.

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

• Directs/mentors other Start Up individuals assigned to support projects of responsibility, as appropriate

• Proactively identifies issues or anomalies in the regulatory process of a study, resolves or brings up as appropriate.

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 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

• Effective oral and written communication skills

• Excellent social 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

• Good judgment and decision-making skills

• Basic medical/therapeutic area and medical terminology knowledge

• Ability to work in a team environment or independently, with minimal supervision, as required

• Ability to mentor fellow SIA team members in a positive and effective manner

• Excellent team player with teambuilding skills

• Basic organizational and planning skills

• Excellent knowledge of all applicable regional / national country regulatory guidelines and EC regulations

Working 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.)

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.