Principal Submission Specialist

Collegeville, Pennsylvania; Waltham, Massachusetts; Research Triangle Park, North Carolina
November 01 2021
Other, Other
Organization Type
Site Name: USA - Pennsylvania - Upper Providence, USA - Massachusetts - Waltham, USA - North Carolina - Research Triangle Park Posted Date: Nov 1 2021 GlaxoSmithKline (GSK) is one of the world's leading research-based pharmaceutical companies. Our powerful combination of skills and resources provide the platform for delivering strong growth and the platform for responding quickly to the rapidly changing global healthcare environment. We are a science-led global healthcare company that researches and develops a broad range of innovative products in three primary areas of Pharmaceuticals, Vaccines and Consumer Healthcare. We have a significant global presence with commercial operations in more than 150 markets, a network of 86 manufacturing sites in 36 countries and large R&D centres in the UK, USA, Spain, Belgium and China. We are currently recruiting a Principal Submission Specialist in our Regulatory Platforms & Systems, Authoring Support Team based in RTP or Philadelphia US. Regulatory Platforms and Systems have accountability for all GRA's operational activity with staff based across 8 countries (US, UK, BE, IT, IN, PO. MX, EG). Through execution of these activities, Regulatory Platforms and Systems facilitates achievement of GRA strategic objectives including support for clinical development, new product launches and obtaining and maintaining GSK product licenses worldwide. This position will be predominantly responsible for timely delivery of CMC compliant regulatory submission packages to Regulatory Authorities by supporting the end-to-end processes in place for clinical applications and major submissions, providing expert guidance on technical requirements to R&D Project Teams, and planning and directing of submission support tasks in collaboration with staff at Global Regulatory Centres (GRC). This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following… Responsible for on-time delivery of Module 2 (QOS) and Module 3 (CMC Standalone and Non-Standalone) electronic applications to Regulatory Authorities for submission types ranging from major, original NCE or Biologic applications through to lifecycle submissions required to maintain application's registered status and fulfil regulatory obligations. Integral member of the Global Regulatory Matrix Teams for high profile R&D projects. Represents CMC Publishing and negotiates agreements with stakeholders on specific technical aspects of major submissions and timelines for delivery which best support the needs of the R&D Project. Accurately estimates scale and timing of publishing tasks and collaborates with Global Publishing Leads, Global Submission Managers, and staff at GRCs to plan and resource for delivery against aggressive timelines. Ensures that CMC documents provided by authors are submission ready and formats to GSK standards as required. Maintains knowledge of relevant Regulatory Authority rules and guidance associated with different formats of regulatory submissions in multiple regions (e.g. eCTD). Building electronic submissions with standard industry software, using validated processes, and adhering to SOPs and Working Instruction documents. Advises and guides CMC Regulatory Exec's on submission structure and publishing/handoff approach. Assists authors with more complex or non-routine content preparation of document management procedures. Provides training when required to Authors populating CMC Templates during Major Marketing Applications. Manages multiple projects/activities at different stages of development at any one time to ensure timely submission or process/system integrity. Why You? Basic requirements: Bachelors degree in a related field Two or more years experience formatting of MS Word documents ensuring GSK requirements and standards are met Two or more years exoerience utilizing document management and publishing software and utilities Two or more years expeirence managing regulations and standards relating to the submission of regulatory applications worldwide Preferred requirements: Demonstrated experience publishing electronic submissions for a Regulatory Authority in a major region (e.g. FDA, EMA) Computer knowledge (e.g. MS Office, Adobe Reader, SharePoint, etc.) and preferably experience with the use of complex IT tools in a large organization (e.g. Veeva Vault) Knowledge of detailed eCTD submission requirements in multiple regions Ability to present and actively communicate electronic submission requirements and processes and champion change, both within Global Regulatory Affairs and with key stakeholder groups in R&D Ability to interpret published external guidance and advise on how to handle internal issues, and respond to technical questions from regulators Project management skills and ability to oversee and prioritize multiple activities across one or more sites for multiple customers Strong sense of urgency, able to prioritize effectively such that key issues or emerging high priority matters are handled in a timely and effective way. Service-oriented attitude and ability to interact effectively with all levels of personnel in an interdisciplinary and matrix environment. Ability to make decisions based on technical knowledge and experience within a regulated framework Ability to function as a team player within a matrixed organization Why GSK? Our values and expectations are at the heart of everything we do and form an important part of our culture. These include Patient focus, Transparency, Respect, Integrity along with Courage, Accountability, Development, and Teamwork. As GSK focuses on our values and expectations and a culture of innovation, performance, and trust, the successful candidate will demonstrate the following capabilities: Operating at pace and agile decision-making - using evidence and applying judgement to balance pace, rigour and risk. Committed to delivering high quality results, overcoming challenges, focusing on what matters, execution. Continuously looking for opportunities to learn, build skills and share learning. Sustaining energy and well-being. Building strong relationships and collaboration, honest and open conversations. Budgeting and cost-consciousness. *This is a job description to aide in the job posting, but does not include all job evaluation details. If requiring an adjustment for a disability, once selected for interview you may contact: When applying for this role, please use the 'cover letter' of the on-line application to describe how you meet the competencies for this role, as outlined in the job requirements above. The information that you have provided in your cover letter and CV will be used to assess your application. . *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 Employer and, in the US, we adhere to Affirmative Action principles. This ensures that 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. At GSK, the health and safety of our employees are of paramount importance. As a science-led healthcare company on a mission to get ahead of disease together, we believe that supporting vaccination against COVID-19 is the single best thing we can do in the US to ensure the health and safety of our employees, complementary workers, workplaces, customers, consumers, communities, and the patients we serve. 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