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Reg Proj Manager, Labeling

Research Triangle Park, NC
Closing date
May 15, 2022

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Site Name: USA - North Carolina - Research Triangle Park Posted Date: Apr 29 2022 Are you looking for a role where you can showcase your process improvement skills? If so, this is the job for you. As Regulatory Affairs Management Professional you will be responsible for leading a process improvement effort across the organization focusing on business alignment, cost and cycle time reduction as well as quality management. This role will provide YOU the opportunity to lead key activities to progress YOUR career, these responsibilities include some of the following: Lead the regulatory process redesign using lean and six sigma methodologies with cross-functional teams resulting in improved process efficiency and quality. Work directly with customers to establish goals and objectives related to lean, process design, including quality targets. Work with subject matter experts to map current and future processes, seek efficiencies, and integrate written standards and training requirements. Prioritize projects to ensure internal resources are appropriately applied to achieve established goals. Establish and monitor metrics relative to process redesigns and implementation. Conduct periodic progress reviews and update senior leadership on the changes and planned deployment. Audit closed projects to ensure results are maintained. Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelor's degree in Science or Life 5+ years relevant experience (in pharmaceutical industry, life sciences research or regulatory). 5+ years Experience using Lean and/or Six Sigma principles 5+ years of process improvement experience Preferred Qualifications: If you have the following characteristics, it would be a plus: Lean and/or Six Sigma Green or Black belt Excellent communication skills at all levels Experience with regulatory audits Successfully performed within a regulated or quality-critical environment such as pharmaceutical industry research, pharmacy, safety or regulatory). Attention to detail, significant experience of document and database management, excellent organization and time management skills to handle multiple projects for different customers. Excellent written and verbal English language communication skills and ability to present information to diverse colleagues in global locations in a clear and concise manner. Ability to think flexibly in order to meet constantly shifting priorities and timelines. Broad understanding of the pharmaceutical industry, drug development environment, development and established product lifecycle maintenance and regulatory processes. Knowledge and understanding of product labelling (e.g. through direct exposure to the management of labelling documents/submissions/data; including label authoring). Experience of maintenance of labelling documents in multiple countries/regions including knowledge of label document content, process and associated regulatory agency labelling requirements. Experience of more than 1 of the following regions/countries: EU PI annexes (including EU CP/MRP/DCP procedures) US PIs Canadian Monographs ROW PIs Experience in authoring and/or updating Labelling SOPs, WIs, QRGs by identifying areas for efficiencies in existing Labelling processes Proficient with computer software applications Familiarity with medical terminology required Ability to lead problem solving and negotiate solutions to complex labeling issues 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. 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. GSK has made the decision to require all US employees to be fully vaccinated against COVID-19, where allowed by state or local law and where vaccine supply is readily available. The only exceptions to this requirement are employees who are approved for an accommodation for religious, medical or disability-related reasons. 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.
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