Senior Country Approval Specialist, Sofia, Bulgaria
длъжност на пълно работно време

Senior Country Approval Specialist, Sofia, Bulgaria

София длъжност на пълно работно време

За нас

About PPD

We are vital links between an idea for a new medicine and the people who need it. We are the people of PPD clinical research services — thousands of employees in locations worldwide connected by tenacity and passion for our purpose: to improve health. You will be joining a truly collaborative and winning culture as we strive to bend the time and cost curve of delivering life-saving therapies to patients.

Our goal-driven teams combine and deliver startup activities for the clinical trials, collaborating to improve processes, cycle and flexibility. We partner with our sites, businesses and colleagues around the world to decrease startup timelines and exceed expectations. 

As a Senior Country Approval Specialist you will be responsible for pulling regulatory Country Submissions together in order to activate investigative sites.

Summarized Purpose:
As a Sr Country Approval Specialist, you are responsible for pulling regulatory Country Submissions together in order to activate investigative sites. You have a strong attention to detail, taking ownership of the accuracy of these documents while holding yourself and others accountable.


Essential Functions:

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.
Provide project specific local Site Intelligence and Activation (SIA) services and coordination of these projects
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 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 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 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.

Изисквания и необходими умения

Job Qualification
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 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 and 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
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 regulation

Ние Ви предлагаме

What we offer:

At PPD clinical research services we hire the best, develop ourselves and each other, and recognize the power of being one team. We understand that you will want to grow both professionally and personally throughout your career, and therefore at PPD clinical research services you will benefit from an award-winning learning and development programme, ensuring you reach your potential.

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 organization but with a local feel.

Our 4i Values:

Integrity – Innovation – Intensity – Involvement

As we are likely to receive many applications, sometimes we are unable to provide feedback to everyone.

Diversity Statement
PPD is proud to be an affirmative action employer that values diversity as a strength and fosters an environment of mutual respect. PPD is committed to providing equal employment opportunities without regard to age, race, color, pregnancy, national origin, religion, sex, gender identity, sexual orientation, disability, veteran status or status within any other protected group.

Информация за контакт

Телефон: +359 2 8048805

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