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Reg Affairs Project Manager, Labeling

Employer
GSK
Location
Research Triangle Park, NC
Salary
Competitive
Closing date
May 22, 2022

View more

Discipline
Other, Other
Job Type
Project Manager
Organization Type
Pharma
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Site Name: RTP Posted Date: May 18 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 Specialist, Country Labelling — Senior 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: • Author and compile Regional/Country PI as per regulatory authority labelling requirements and GSK process and standards. • Author and compile market-specific supporting documentation for labelling submissions in accordance with regulatory authority requirements and GSK process and standards. • Provide support to global and local GRA team members through preparation of other labelling documents as required • Complete quality and consistency checks of labelling document content. • Efficiently coordinate and manage labelling documentation and data in regulatory systems. • Provide advice regarding regulatory authority labelling requirements and GSK labelling process and standards to GRA global/local roles and via Regulatory Matrix Teams. • Effectively communicate with GSK staff (including GRA, Global safety and medical, and Local Operating Companies) to author, compile and deliver quality labelling documents. May communicate with Regulatory Agencies and third parties on behalf of GRA labelling staff. • Support other regulatory functions and participate in other projects and activities as needed, such as contributing to the implementation of changes to labelling processes and evaluation of new agency labelling requirements. • For some roles, may be required to perform translation of labelling text into identified languages. • May become a SME in country/regional labelling content and process Why you? Basic Qualifications: We are looking for professionals with these required skills to achieve our goals: Bachelors degree or equivalent work experience 2+ years relevant experience (in pharmaceutical industry, life sciences research or regulatory). Experience of XML Labelling. The ability to understand the scientific content of complex labelling documents. Experience in a regulated or quality-critical environment such as pharmaceutical industry research, pharmacy, safety or regulatory Experience in updating and managing Regional/Country Labeling documents. Proficient with computer software applications Familiar with medical terminology Ability to negotiate solutions to moderate labeling issues and proactively identify improvements for labelling processes Knowledge of labelling regulations/requirements in 1 or more regions. Preferred Qualifications: If you have the following characteristics, it would be a plus: Masters degree or equivalent work experience Attention to detail, significant experience of document and database management, excellent organization and time management skills to handle multiple tasks. Broad understanding of the pharmaceutical industry, drug development environment, and regulatory processes. Regulatory document management experience (particularly experience of working with and amending Product Information/Labelling Documents). Experience and familiarity of working within regulatory systems and communication tools. Some experience of managing local and global labelling documents and submissions. Experience of communicating with regulatory agencies. Experience of EU (including Linguistic review) and US label content and requirements. Why GSK? 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/ViiV Healthcare, please 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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