Signatory Lead
Job Summary
Salary Range:
67900.00 - 126100.00Job Description Summary
The Signatory Lead is accountable for ensuring that promotional and non-promotional materials and activities comply with the ABPI Code of Practice The Signatory Lead is accountable for ensuring that promotional and non-promotional materials and activities comply with the ABPI Code of Practice applicable regulations and Novartis policies. Acting as a final medical signatory they provide expert guidance on code and compliance matters enabling informed decision-making and effective risk management across the organisation. The Signatory Lead partners closely with Medical Commercial ERC and cross-functional stakeholders throughout the lifecycle of projects contributing to strategy development content creation review and approval processes and governance activities to ensure materials are scientifically robust high quality compliant and aligned with business objectives.Job Description
Major Accountabilities
- Acts as the final medical signatory for allocated therapy areas providing expert guidance on the ABPI Code of Practice relevant regulations and Novartis policies and serving as the primary point of contact for code and compliance advice.
- Responsible for the review and certification of promotional and non-promotional materials and activities within Novartis approval systems ensuring compliance scientific accuracy and appropriate risk management.
- Acts as a subject matter expert on the ABPI Code of Practice industry regulations and internal governance requirements providing pragmatic risk-based advice to support business objectives.
- Partners closely with Medical Commercial ERC and cross-functional stakeholders to co-create strategies projects and tactical plans embedding compliance considerations from concept through to approval implementation and lifecycle management.
- Supports the management of PMCPA complaints audits and inspections contributing to root cause analysis corrective actions and continuous improvement initiatives.
- Drives quality and consistency in review and approval activities by sharing best practice coaching stakeholders and providing constructive feedback to enhance compliance standards across the organisation.
- Builds and maintains effective relationships with external vendors and service providers identifying opportunities to optimise processes quality efficiency and compliance.
- Collaborates with Signatory and Ethics Risk & Compliance colleagues to promote consistent enterprise-wide approaches to governance decision-making and materials review.
- Identifies and implements process improvement opportunities that enhance operational efficiency simplify ways of working and improve stakeholder experience while maintaining compliance.
- Effectively prioritises workload and adapts to changing business needs demonstrating agility and resilience in a dynamic environment.
- Role models Novartis values culture and behaviours fostering collaboration accountability innovation and a patient-focused mindset.
Key Performance Indicators
- Compliance with ABPI code of Practice / other industry regulationsand Internal Novartis Policies
- Approval of Novartis Materials within timelines specified within Novartis SOPs
- No critical deviations from Novartis policies processes SOPs/WPs/FRMs
- Audit & Inspection readinessat all times.
- Compliance with Novartis Information Security
- Training completed and up to date with 98% compliance.
Ideal background
- University degree in life sciences marketing business or a related field.
- GMC registered Physician orGPhCregistered Pharmacist
- English
- Country language required
Relevant Experiences
- Significant experienceinMedicalaffairs in a final signatory role or relevant skills and experience to become a registered signatory in a shorttimeframe.
- Experience in PMCPA code complaints beneficial
- Strongunderstanding of the ABPI codewith a solutions-oriented approach to the grey areas
- Demonstrates a customer-focused mindset.
- Good Enterprise & Strategic mindset with courage to challenge status quo.
- Innovative and creative approach to complex problem solving and confidence to make decisions.
- Hassolutionorientated mindset and can effectivelyidentifyand overcome challenges but remain flexible to evolving needs of business.
- Strong communication interpersonal and influencing skills
- Good planning andorganisationalskills
- Able to adapt organize prioritize and work effectively and collaboratively in multifunctional team
Benefits & Rewards
At Novartiswerecommitted to reimagining medicine together - and rewarding the people who make it happen.
Expected Annual Base Salary Range for role:67900.00 - 97000.00 - 126100.00 GBP Annual
The base salary offered isdeterminedbased on gender-neutralobjectives such as relevant skillscompetenciesand experiencein accordance withthe Novartis pay setting policy and upon joining Novartis will be reviewed periodically.
In addition to your base salary you may be eligible for a performance-based bonus depending on certain performance parameters.
The rewards of being part of our team go far beyond base pay and incentives. We also offer a variety of competitive benefits inkindto help you thrive personally and professionally such as insurance plans retirement plans wellbeingresourcesand global recognition addition we provide flexible and hybrid working options where possible andminimum14 weekspaid parental leave.
You may be eligible for a company vehicle or a car allowancein accordance withthe applicable local Novartis policies and guidelines.
Pay equity is a fundamental principle of our employment policy and reflects our commitment to create a diverseequitableand inclusive environment that treats all employees with dignity and respect as outlined in our Code of Ethics.
Read our brochure to learn more about our global total rewards offering:
Skills Desired
Clinical Research Clinical Trials Detail-Oriented Medical Writing Regulatory ComplianceAbout Company
Novartis is a global healthcare company based in Switzerland that provides solutions to the evolving needs of patients worldwide.