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Senior Manager, Healthcare Compliance Monitoring and Process, Established and International

Employer
Astellas Europe
Location
Addlestone, Surrey
Salary
Competitive + Benefits
Start date
2 Sep 2021
Closing date
2 Oct 2021

View more

Discipline
Regulatory Affairs, Compliance
Hours
Full Time
Contract Type
Permanent
Experience Level
Management

Job Details

Senior Manager, Healthcare Compliance Monitoring and Process, Established and International

About Astellas:

At Astellas we are a progressive health partner, delivering value and outcomes where needed We pursue innovative science, focussing initially on the areas of greatest potential and then developing solutions where patient need is high, often in rare or under-served disease areas and in life-threatening or life-limiting diseases and conditions. We work directly with patients, doctors and health care professionals on the front line to ensure patient and clinical needs are guiding our development activities at every stage. We work closely with regulatory authorities and payers to find new ways to ensure access to new therapies. We deliver the latest insights and real-world evidence to inform the best decisions for patients and their care-givers, to ensure the medicines we develop continue to provide meaningful outcomes. Beyond medicines, we support our stakeholder communities to drive initiatives that improve awareness, education, access and ultimately standards of care.

About This Job

This is an exciting opportunity for an experienced Compliance expert to join the Global E&C team to drive compliant and efficient Healthcare Compliance operations for Established and International Markets by working with affiliates, Regional and Global colleagues in line with applicable laws, regulations, Codes of Practice and Astellas policies and processes.

You will serve as the SME/strategic business partner for assigned functions including without limitation Medical Affairs and Government Affairs, you will be assigned to the Oncology products/therapy areas and any other functions supporting these areas within Established and International Markets.

You will play a key role in the development and implementation of compliance strategies, tactics and materials and provide direct support and advice to help business colleagues adhere to the Company’s highest ethical and compliance standards through all stages of product life cycle management.

This role will also participate in cross-functional project teams and support Ethics and Compliance Leadership in developing and implementing strategic initiatives to enhance compliance policies.

As the SME you will lead on and be accountable for the design and delivery of the monitoring programme for above country (Regional or Global) activities delivered by the business for execution at affiliate level.  Monitors to ensure compliance with the new above country (Regional or Global) model for review and approval of materials and activities.  Leads on and accountable for the design of monitoring for business owned first line checks on activities led out of Established/APEL/International.  Directs HCC team to complete assigned monitoring tasks and key contact with E&C CET team on Monitoring initiatives and roll out for APEL/Above Country (Global). 

Essential Knowledge & Experience

  • Previous pharmaceutical industry experience within Compliance, Legal, Medical Affairs or Commercial 
  • Proven previous Healthcare Compliance experience to understand and comply with IFPMA, EFPIA or ABPI Code of Practice, preferably with knowledge of cross-border differences
  • Active involvement in Code related issues
  • Experience of compliance systems e.g. Veeva Vault PromoMats
  • Proven experience in regulatory requirements within the pharmaceutical industry
  • Experience in the creation of company policies, processes and procedures within a Quality framework
  • Coaching and collaboration skills to interact with all levels of personnel to achieve shared goals.
  • Proven ability to influence, (appropriately) challenge and engage diverse senior stakeholders. 
  • Fluent in written and verbal business English

Preferred Knowledge & Experience

  • This role would suit an individual with experience in ethics, compliance or a legal background.

Educations/Qualifications

  • Graduate, preferably BSc or equivalent professional qualification.

Company

At Astellas, we believe that nurturing exceptional relationships with our employees delivers exceptional results. We can offer an inspiring place to work and a chance to make your mark in doing good for others.

Our expertise, science and technology make us a pharma company. Our open and progressive culture is what makes us Astellas. It’s a culture of doing good for others and contributing to a sustainable society. Delivering meaningful differences for patients is our driving force. We all have a significant opportunity to make that difference, working locally in the areas we know best, whilst drawing inspiration from the different insights and expertise we have access to globally and from our innovative, external partners.

Our ethos is underpinned by the Astellas Way, comprising five core values: patient focus; ownership; results; openness and integrity.

We are proud to offer an inclusive and respectful working environment that fosters collaboration and ownership. Our aspiration is to bring the best brains together, to provide them with world-leading tools and resources and a unique structure that fosters real agility and entrepreneurial spirit.

For more information about our current career opportunities and how you can make a difference please visit https://www.astellas.com/eu/careers

Company info
Website
Location
300 Dashwood Lang Road,
Bourne Business Park
Addlestone
KT15 2NX
GB

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