Country Approval Specialist
Country Approval Specialist
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Job Description
Work Schedule
Standard Office Hours (40/wk)Environmental Conditions
OfficeJob Description
Summarized Purpose:
Manages the preparation review and coordination of Country Submissions in line with global submission strategy.
Key responsibilities:
- Prepares review and coordinates submissions (MoH EC applications if e.g. gene therapy approvals safety dossiers import license) in alignment with global submission strategy.
- Provides strategy advice (MoH &/or EC) to clients.
- Develops and implements local submission strategy. Provides expertise and coordination oversight for projects in collaboration with relevant internal departments.
- Serves as primary contact for investigators and with the local authorities (in collaboration with the local regulatory manager for sophisticated 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 the need arises 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 PPDs target cycle times for site activations.
- Prepares the regulatory compliance review packages as applicable.
- Liaise within SIA 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 SIA activities are accurately maintained in the database and is current at all times.
- Oversees country study files and ensures that they meet PPD WPDs or client SOPs.
- Maintains knowledge of and understand PPD SOPs Client SOPs/directives and current regulatory guidelines as applicable to services provided.
- Advises/mentos other SIA individuals assigned to support projects of responsibility as appropriate
- Proactively identifies issues or anomalies in the regulatory process of a study resolves or escalates as appropriate.
Keys to Success
Education and Experience:
Bachelors degree or equivalent and relevant formal academic / vocational qualification
Previous experience that provides the knowledge skills and abilities to perform the job (comparable to 5 years).
Knowledge Skills and Abilities:
- Effective oral and written communication skills
- Excellent interpersonal skills
- Strong attention to detail and quality of documentation
- Good negotiation skills
- Good digital literacy 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 direction 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
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 100000 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!
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-*. 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.
Required Experience:
Unclear Seniority
Employment Type
Full-Time
