Job Description
Summarized Purpose:
Participates in the management and preparation, review and coordination of Country Submissions in line with global submission strategy.
Essential Functions and Other Job Information:
- 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 SIA 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 PPD’s target cycle times for site.
- May work with the start-up CRA(s) to prepare the regulatory compliance review
packages, as applicable.
- 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 SIA activities onto PPD
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 PPD WPDs or applicable client SOPs.
- Maintains knowledge of and understand PPD SOPs, Client SOPs/directives, and
current regulatory guidelines as applicable to services provided.
Job Complexity
Works on problems of moderate scope where analysis of situations or data requires
a review of a variety of factors.
Job Knowledge
Developing professional expertise, applies company policies and procedures to
resolve a variety of issues.
Supervision Received
Normally receives general instructions on routine work, detailed instructions on new
projects or assignments. Exercises judgment within defined procedures and
practices to determine appropriate action.
Business Contacts are primarily internal to the company with infrequent external customer /
Relationships vendor contact on routine matters. Builds productive internal / external working
relationships.
Qualifications:
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 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 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
- 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
