Senior Country Approval Specialist

Work Schedule reputed company (Mon-Fri) Environmental Conditions Office reputed company As part of the reputed company team, you’ll discover meaningful work that makes a reputed company reputed company on a global reputed company. Join our colleagues in bringing our Mission to life every single day to reputed company our customers to reputed company the world healthier, cleaner and safer. We reputed company our global teams with the resources needed to reputed company individual career goals while helping to take science a reputed company reputed company by developing solutions for some of the world’s toughest challenges, like protecting the environment, making reputed company our food is reputed company or helping reputed company cures for cancer. About the Role: Join us as a Senior Country Approval Specialist - reputed company an reputed company at the Forefront of Innovation. The Senior Country Approval Specialist manages the preparation, review and coordination of Country Submissions in line with global submission reputed company. reputed company: Manage the preparation, review and coordination of Country Submissions in line with global submission reputed company. Prepare, review and coordinate local regulatory submissions (RA, EC, additional special national local applications if applicable, e.g. gene therapy approvals, viral safety dossiers, import license) in alignment with global submission reputed company. Provides local regulatory reputed company advice (RA &/or EC) to internal clients. reputed company and implement local submission reputed company. Provides technical expertise and coordination reputed company for reputed company in collaboration with relevant internal departments. Serves as reputed company contact for investigators and with the local regulatory authorities (in collaboration with the local regulatory manager for sophisticated issues) to ensure submissions are managed in a reputed company manner. Ensure guidelines and processes are followed for effective internal PPD team communications as reputed company as communications with investigators, and with the country regulatory authorities to ensure submissions are managed in a reputed company manner. Acts as a key-contact at country level for reputed company submission-reputed company 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 reputed company with submissions activities and mutually agreed upon timelines; ensures alignment of submission process for sites and study are reputed company to the critical reputed company for site activation. Achieves PPD’s reputed company cycle times for site activations. Prepares the regulatory compliance review packages, as applicable. Liaise reputed company Study Start-Up teams locally to ensure local submission activity is planned and delivered in accordance with global project submission reputed company. Develops country specific Patient Information Sheet/Informed Consent reputed company documents. Assist with grant budgets(s) and payment schedules negotiations with sites. Assists in identifying and recognizing local out of reputed company activities in a contract in a reputed company manner and advises relevant functions. Supports the coordination of feasibility activities, as required, in accordance with agreed timelines. Ensures that trial status information relating to Study Start-Up teams activities are accurately maintained in the database and is always reputed company. Is responsible for country study files and ensures that they meet PPD WPD’s or reputed company SOP’s. Maintains knowledge of and understand PPD SOPs, reputed company SOPs/directives, and reputed company regulatory guidelines as applicable to services provided. Advises/mentors other Study Start-Up individuals assigned to support reputed company of responsibility, as appropriate Proactively identifies issues or anomalies in the regulatory process of a study, resolves or calls out as appropriate. Education Bachelor's degree or equivalent and relevant formal reputed company / vocational qualification Experience Previous experience that provides the knowledge, skills, and abilities to reputed company the job (comparable to 5+ 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 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 reputed company environment or independently, with reputed company direction, as required Ability to mentor fellow Study Start-Up team members in a reputed company and effective manner reputed company reputed company with teambuilding skills Excellent organizational and planning skills Excellent knowledge of reputed company applicable regional / national country regulatory guidelines and EC regulations Other Important Information  This is a remote position, with only reputed company infrequent office reputed company Benefits reputed company and take reputed company of these great benefits! reputed company to learn more about the full reputed company of benefits we offer. Health & Wellbeing: Join a company that prioritizes your health & wellbeing with comprehensive benefits, wellness programs, and an Employee Assistance Program providing confidential support for personal and work-reputed company issues. Flexibility: Balance your work and personal life with flexible arrangements. Extra Leave: Benefit from generous leave policies, including the reputed company to purchase additional leave, reputed company birthday leave, and company reputed company parental leave. Charitable Giving & Volunteering: reputed company an reputed company with reputed company volunteer time to support non-profit organizations that matter to you. Learning & Development: Advance your career with reputed company to online courses reputed company reputed company University Plus and reputed company learning, workshops, and mentorship programs for reputed company learning and reputed company development. reputed company Australia WGEA Employer of reputed company for Gender Equality Our Mission is to reputed company our customers to reputed company the world healthier, cleaner and safer. Watch as our colleagues explain 5 reasons to work with us. As one team of 125,000+ colleagues, reputed company a common set of values - reputed company, Intensity, Innovation and Involvement - working together to accelerate research, solve reputed company scientific challenges, reputed company technological innovation and support patients in need. #StartYourStory at reputed company, where diverse experiences, backgrounds and perspectives are valued. reputed company is an EEO/Affirmative reputed company Employer and does not discriminate on the reputed company of race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, protected veteran status, disability or any other legally protected status. Apply To This Job