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Core Competencies
Role fitCore Competencies
Use this summary to align your resume positioning with the role.
Demonstrates expertise in authoring and managing regulatory labelling documentation, including Global Datasheets and US/EU prescribing information, while effectively collaborating with cross-functional teams and stakeholders. Possesses strong communication skills and a solid foundation in pharmacy or life sciences, with a focus on oncology and regulatory affairs.
Highest-signal resume keywords
Regulatory Labelling ManagementStakeholder ManagementScientific AuthoringCross-Functional CollaborationOncology Experience
ATS Keywords
Tailor your resumeApplicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard Skills
Regulatory AffairsLabelling DocumentationScientific WritingRisk AssessmentData Management
Soft Skills
Communication SkillsMentoringProblem Solving
Tools & Technologies
Veeva Vault
Certifications & Qualifications
Degree in PharmacyDegree in Life SciencesAdvanced Degree (MSc, MPharm, PhD)
Industry Keywords
PharmacovigilanceClinical ResearchMedical AffairsTherapeutic AreasPatient Information
Tech Stack
Tools & technologiesVault
About the role
Key responsibilities & impact- Lead development, authoring and maintenance of Global Datasheets for new medicines, product line extensions and early lifecycle products
- Manage local prescribing and patient information through development and early post-approval stages, including US Prescribing Information, EU SmPC, patient information leaflets, labels and other regional product information
- Partner with global markets to implement Global Datasheets into country and regional prescribing and patient information
- Manage key country labelling differences
- Author regulatory responses and supporting documentation for Regulatory Authorities and Labelling Governance Committees
- Interface with labelling, regulatory, clinical, safety, governance and operational stakeholders
- Align labelling strategy, resolve issues and support decision-making in a complex matrix environment
- Maintain labelling documentation, data and processes in relevant systems and databases, including Veeva Vault
- Mentor colleagues on labelling processes, support governance meetings and represent GSK externally where required
Requirements
What you’ll need- Degree in Pharmacy, Life Sciences, Biomedical Sciences or related discipline with experience in a relevant scientific, pharmacy or healthcare-related field
- Experience with stakeholder management and collaboration in complex matrix teams
- Two or more years of experience interpreting complex scientific information, assessing risks and benefits, drawing on multiple sources, and resolving conflicts
- Two or more years of experience collaborating effectively in cross-functional environments
- Strong written and verbal English communication skills (preferred)
- Relevant labelling or related experience across pharmacy, regulatory affairs, medical affairs, clinical research, pharmacovigilance or therapeutic areas (preferred)
- Strong track record of authoring scientific labelling text, prescribing information or patient-facing content (preferred)
- Experience working in oncology (preferred)
- Advanced degree such as MSc, MPharm, PhD or equivalent (preferred)
Benefits
Comp & perks- Annual bonus
- Eligibility to participate in share-based long-term incentive program
- Health care and other insurance benefits for employee and family
- Retirement benefits
- Paid holidays
- Vacation
- Paid caregiver/parental and medical leave