Jobs in Cambridge, east anglia, united kingdom

At Gilead were creating a healthier world for all people. For more than 35 years weve tackled diseases such as HIV viral hepatitis COVID19 and cancer working relentlessly to develop therapies that help improve lives and to ensure access to these therapies across the globe. We continue to fight against the worlds biggest health challenges and our mission requires collaboration determination and a relentless drive to make a difference.

Every member of Gileads team plays a critical role in the discovery and development of lifechanging scientific innovations. Our employees are our greatest asset as we work to achieve our bold ambitions and were looking for the next wave of passionate and ambitious people ready to make a direct impact.

We believe every employee deserves a great leader. People Leaders are the cornerstone to the employee experience at Gilead and Kite. As a people leader now or in the future you are the key driver in evolving our culture and creating an environment where every employee feels included developed and empowered to fulfil their aspirations. Join Gilead and help create possible together.

Job Description

FUNCTION : Regulatory Affairs (RA) Labeling

POSITION OVERVIEW :

Regulatory Affairs Labeling is a core function within Gileads Global Regulatory Affairs organization and acts as a critical strategic partner across crossfunctional teams. Regulatory Affairs Labeling creates updates and maintains product information and labeling documentation for all relevant Gilead products across our product portfolio. Product information and labeling documentation contains the most accurate product use benefits dosage / application and safety information such as side effects and other safety guidelines for patients and healthcare providers. Regulatory Affairs Labeling plays a key role in providing regulatory strategy and expertise to drive operational excellence in endtoend processes for RA labeling translations and artwork as well as ensuring that product labeling and associated documents comply with governing laws regulations and company policies and procedures. Regulatory Affairs Labeling collaborates closely with crossfunctional partners including other Regulatory and Development teams Legal Commercial and external third parties such as strategic partners translation vendors and regulatory agencies to ensure compliant timely and appropriate delivery of product information labeling translations and artwork updates.

This role will provide leadership and oversight for vendor governance strategic sourcing partnerships and initiatives supporting Global Labeling. You will work across Gilead Kite and external vendors to manage strategic sourcing needs across global labeling translations and artwork. Your responsibilities will include building and maintaining strong relationships with vendors identifying needs negotiating contracts seeking opportunities for cost savings risk mitigation and supply chain optimization with suppliers.

You will be a member of the Global Labeling Team with considerable responsibilities to develop continuously improve and innovate global regulatory and labeling policies practices processes tools team and other capabilities.

EXAMPLE RESPONSIBILITIES :

Oversees the management and direction of global outsourcing partners and service providers supporting labeling translations and artwork activities.

Responsible for partnership management to include contract negotiations discussing new work requirements expectations and volumes managing role descriptions for suppliers monitoring KPIs metrics supplier compliance and deviations supplier CAPA involvement in collaboration with the Quality team issue resolution managing a centralized budget for translations and approving POs and invoices within finance system.

Coordinates communication between global outsourcing partners and relevant internal stakeholders including Global Labeling Regulatory Affairs and Labeling Operations (Artwork) to ensure timely and appropriate interactions and effective labeling compliance and .

Leads the definition development implementation and continuous improvement of processes and initiatives with service providers aligning processes and creating / updating procedural documents as applicable.

Partners with Vendor Governance and attends relevant meetings to provide updates relating to strategic sourcing. Sets up and attends regular vendor meetings and develops and maintains relationships. Develops training material and provides vendor trainings for outsourced activities.

Provides input into systems used and technology discussions with vendors for example Translation Management system & AI for translations.

Supports outsourcing partner inspection readiness activities when applicable including support of audits for applicable vendors.

REQUIREMENTS :

We are all different yet we all use our unique contributions to serve patients. Please see the following for the qualifications and skills we seek for this role.

Education & Experience

A good level of experience in prescription drug labeling

Experience leading global teams and projects in regulatory or related strategies programs projects and other activities.

Leadership experience with high complexity crossfunctional initiatives including team and governance management strategy setting and effective oversight of strategy .

Experience driving inspection readiness and quality processes across the endtoend labeling process.

Strong track record of cultivating and maintaining strategic relationships and collaborations both internally and externally.

Experience in vendor governance and managing vendor relationships ensuring costeffective operations strong project management skills and the ability to manage complex projects and developing strategic partnerships to support global labeling initiatives.

Knowledge & Other Requirements

Familiarity with vendor management / oversight.

Working knowledge of the drug development process.

Knowledge of the biopharma industry including indepth understanding of other business functions including artwork and manufacturing.

Indepth knowledge in labeling operations compliance including quality management processes and systems.

Indepth knowledge of systems tools metrics and digital technologies to support global labeling.

Indepth knowledge of labeling artwork and translation requirements and guidance including industry best practices and standards.

Demonstrates advanced regulatory and business knowledge and advanced analytical abilities as evidenced by strengths in assessing complex multidisciplinary data understanding and effectively advising on regulatory implications.

Proven ability to influence up down and across the organization and externally in a collaborative manner.

Ability to lead and influence programs projects and / or initiatives.

Exceptional interpersonal skills and understanding of team dynamics.

Strong communication and organizational skills. Able to distill complex matters into a clear business case and roadmap for . Demonstrated ability to align other leaders and garner their commitment and engagement to crossfunctional strategies plans and strategic objectives.

Strong negotiation and conflict resolution skills.

Advanced coaching capabilities to mentor / develop staff.

When needed ability to travel.

Equal Employment Opportunity (EEO)

It is the policy of Gilead Sciences Inc. and its subsidiaries and affiliates (collectively Gilead or the Company) to recruit select and employ the most qualified persons available for positions throughout the Company. Except if otherwise provided by applicable law all employment actions relating to issues such as compensation benefits transfers layoffs returns from layoffs companysponsored training education assistance social and recreational programs are administered on a nondiscriminatory basis (i.e. without regard to protected characteristics or prohibited grounds which may include an individuals gender race color national origin ancestry religion creed physical or mental disability marital status sexual orientation medical condition veteran status and age unless such protection is prohibited by federal state municipal provincial local or other applicable laws). Gilead also prohibits discrimination based on any other characteristics protected by applicable laws.

For Current Gilead Employees and Contractors :

Please apply via the Internal Career Opportunities portal in Workday.

Required Experience :

Manager

Key Skills

Proofreading,Adobe Acrobat,FDA Regulations,Manufacturing & Controls,Biotechnology,Clinical Trials,Research & Development,GLP,cGMP,Product Development,Chemistry,Writing Skills

Employment Type : Full-Time

Experience : years

Vacancy : 1