Senior Offer Development Analyst
Medtronic
Director, Content Approval - Quality and Training
GSK
full-time
Posted on:
Location Type: Office
Location: Upper Providence • Pennsylvania • 🇺🇸 United States
Visit company websiteJob Level
Lead
About the role
- Manage quality control processes (incl. established KPI and SLAs) within content approval including ABPI examination and certification
- Identify, assess, and execute/manage actions to mitigate risks associated with content approval operations
- Review and identify trends from reports on quality performance, compliance status, operational effectiveness and improvement initiatives
- Recommend possible actions for continuous improvement and engage with GMI CA Leadership and business partners
- Act as subject matter expert on content approval process and serve as key point of contact for audits and inspections
- Develop and implement robust content approval management monitoring and ensure timely completion of CAPAs
- Act as deputy global process owner for approval of promotional and non-promotional materials and partner with global process owner
- Identify training needs, develop and deliver comprehensive training strategy and onboarding curriculum for Content Approval team members
- Ensure vendors for content review and approval have necessary training on GSK requirements/processes
- Partner with ABPI Directors, GMI&CA leadership and internal stakeholders (Compliance, Legal, Regulatory, Commercial) to keep training current
- Conduct refresher training as needed to ensure high quality and compliance
Requirements
- Master’s/Graduate Degree in Life Sciences or Healthcare
- 6+ years of pharmaceutical industry experience
- 3+ years of Medical Affairs experience
- Strong understanding of content approval requirements including external regulations (e.g. ABPI Code)
- Experience in quality and compliance oversight including audits and inspections
- Experience in the development and delivery of training and onboarding programs
- Experience managing vendors for content review and approval
- Subject matter expertise in content approval processes
- Experience developing and delivering comprehensive training strategies and onboarding curricula
- Preferred: Experience in digital transformation and technology solutions to enhance training and operations
- Preferred: Leadership experience in cross-functional teams within a matrixed organization
- Preferred: Experience working at both global and local country level
- Preferred: Ability to analyze external environment and translate to strategy, execute and embed change initiatives
- Preferred: Strong collaboration, delegation and teamwork skills
Benefits
- Please visit GSK US Benefits Summary to learn more about the comprehensive benefits program GSK offers US employees.
ATS Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
quality control processesKPISLAABPI examinationCAPAcontent approval managementauditsinspectionstraining strategyonboarding curriculum
Soft skills
leadershipcollaborationdelegationteamworkrisk managementcontinuous improvementcommunicationtraining deliverystakeholder engagementsubject matter expertise
