Senior Manager, Healthcare Compliance Monitoring and Process, Established and InternationalAbout 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
Preferred 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
- This role would suit an individual with experience in ethics, compliance or a legal background.
- Graduate, preferably BSc or equivalent professional qualification.