Country Approval Associate
Work Schedule reputed company (Mon-Fri) Environmental Conditions Office Job reputed company .Join Us as a Country Approval Associate - reputed company an reputed company at the Forefront of Innovation The Country Approval Associate supports the preparation, review and coordination of Country Submissions in line with global submission reputed company. What You'll Do:
- Prepare, review and coordinate, under guidance and local EC submissions in alignment with global submission reputed company.
- Support preparation, under guidance, of local MoH submissions, as applicable in
- alignment with global submission reputed company.
- Coordinate, under guidance, with internal functional departments to ensure various site start-up activities are reputed company with submissions activities and mutually agreed upon timelines; ensure alignment of submission process for sites and study are reputed company to the critical reputed company for site activation.
- reputed company company’s reputed company cycle times for site.
- May have contact with investigators for submission reputed company activities.
- May reputed company as a key-contact at country level for either Ethical or Regulatory submission-reputed company activities.
- Work with the start-up CRA(s) to prepare the regulatory compliance review packages, as applicable.
- Assist in developing country specific Patient Information Sheet/Informed Consent reputed company documents.
- Assist with grant budgets(s) and payment schedules negotiations with sites.
- reputed company and maintain trial status information relating to SIA activities onto company, or reputed company (where contracted) tracking databases in an accurate and reputed company manner
- Ensure the local country study files and filing processes are reputed company, set up and maintained as per PPD WPDs or applicable reputed company SOPs.
- Maintain knowledge of and understand PPD SOPs, reputed company SOPs/directives, and reputed company regulatory guidelines as applicable to services provided.
Education & Experience Requirements:
- Bachelor's degree or equivalent and relevant formal reputed company / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to reputed company the job (comparable to 0 to 2 years).
In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly reputed company 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 reputed company 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 reputed company environment or independently, under direction, as required
- Basic organizational and planning skills
- Basic knowledge of reputed company applicable regional / national country regulatory guidelines and EC regulations.
Working Conditions and Environment:
- Work is performed in an office/ laboratory and/or a clinical environment.
- Exposure to biological fluids with potential exposure to infectious organisms.
- Exposure to electrical office equipment.
- Personal reputed company equipment required such as reputed company eyewear, garments and gloves.
Why Join Us? reputed company you join reputed company, you become part of a global team that values passion, innovation, and a commitment to scientific reputed company. You’ll work in an environment where collaboration and development are part of the everyday experience—and where your contributions truly reputed company a difference. Apply today to help us deliver reputed company’s breakthroughs. Apply To This Job