Junior Regulatory Specialist, Submission Delivery Publishing

Site Name: Poznan Grunwaldzka Posted Date: Jul 19 2022 Junior Submissions Delivery Specialist will be responsible for producing submissions delivered to Regulatory Authorities worldwide in support of the entire product lifecycle, ensuring that all submissions are produced as specified by GSK delivery teams (time and content) and are compliant with appropriate Regulator’s electronic submission standards. Responsibilities: • Assemble, link and publish submission packages that meet Regulatory Authority technical standards and GSK requirements and schedules • Advising and assisting authors with the preparation of submission content and use of GSK document management systems and procedures • Check compliance of others’ work with requirements and standards • Maintaining knowledge of relevant Regulatory Authority rules and GSK standards associated with submission format • Lead the creation and implementation of publishing working practices and procedures aimed at simplifying processes and increasing quality • Interpreting and correcting technical validation errors, identifying and resolving issues with source documents, working with authors and requestors as necessary to rectify any problems that prevent completion of the publishing job • Regular interactions with publishing staff globally Basic qualifications: • University Student or Graduate (preferable in scientific field or English philology) available to work full-time hours • Computer knowledge (e.g. MS Office, Adobe Reader, SharePoint, etc.) and preferably experience with the use of complex IT tools in a large organization • Fluent Polish and English (both written and spoken) • Paying attention to detail and ability to follow detailed procedures consistently • Ability to work carefully under time constraints, • Excellent interpersonal, communication, customer service skills • Demonstrate a versatile, flexible approach by adapting to challenging and changing demands • Ability to function as a team player within a matrixed organization Preferred qualifications: • Work experience with tools (e.g. Adobe Acrobat, SharePoint, Documentum, Citrix, Remote desktop) • Experience in document management • Experience in fields related to regulatory affairs • Experience in publishing electronic submissions for a Regulatory Authority We offer: • Stable and interesting job in one of the leading global healthcare companies. • Access to newest technologies and solutions. • Friendly work environment and great atmosphere in our teams. • Possibilities of development within the role and company’s structure. • Benefits (e.g. private medical healthcare, life insurance, sports card, pension plan, flexible working hours, home office). • Corporate culture based on our values: patient focus, integrity, respect and transparency. *LI-GSK If you require an accommodation or other assistance to apply for a job at GSK, please contact the GSK Service Centre at 1-877-694-7547 (US Toll Free) or +1 801 567 5155 (outside US). GSK is an Equal Opportunity/Affirmative Action Employer. All qualified applicants will receive equal consideration for employment without regard to race, color, national origin, religion, sex, pregnancy, marital status, sexual orientation, gender identity/expression, age, disability, genetic information, military service, covered/protected veteran status or any other federal, state or local protected class. Important notice to Employment businesses/ Agencies GSK does not accept referrals from employment businesses and/or employment agencies in respect of the vacancies posted on this site. All employment businesses/agencies are required to contact GSK's commercial and general procurement/human resources department to obtain prior written authorization before referring any candidates to GSK. The obtaining of prior written authorization is a condition precedent to any agreement (verbal or written) between the employment business/ agency and GSK. In the absence of such written authorization being obtained any actions undertaken by the employment business/agency shall be deemed to have been performed without the consent or contractual agreement of GSK. GSK shall therefore not be liable for any fees arising from such actions or any fees arising from any referrals by employment businesses/agencies in respect of the vacancies posted on this site. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment. This capture of applicable transfers of value is necessary to ensure GSK’s compliance to all federal and state US Transparency requirements. For more information, please visit GSK’s Transparency Reporting For the Record site.