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Regional Medical Affairs Operations Lead-Seqirus

Maidenhead, Berkshire, Maidenhead, United Kingdom

Posted: 8-Sep-2016

Ref#: 12345698384


Are you looking for a rewarding career in a market-leading and innovative company?

Seqirus is the new global company created from the combined strength and expertise of bioCSL and the influenza vaccines business formerly owned by Novartis. In July 2015, bioCSL and the influenza vaccines of Novartis joined forces to create Seqirus, now the second largest influenza vaccine company in the world.  With extensive research and production expertise and manufacturing plants in the US, UK, Germany and Australia, Seqirus is a transcontinental partner in pandemic preparedness and a major contributor to the prevention and control of influenza globally. Seqirus has a workforce of over 2,000 employees, significant manufacturing capacity and a commercial presence in 20 countries.


Reporting Relationships:

This role reports to Regional Head of Medical Affairs, EU and ME and Americas.


Job Summary:

To oversee the Regional Medical Affairs Operations and Medical Information function which facilitates the quality use of Seqirus products, ensure safety information and spontaneous adverse event reports are captured and reported correctly and oversee Medical Affairs systems and processes to ensure compliance, with the following objectives:

  • Plan directs and tracks operational and financial functions for Seqirus' Regional Medical Affairs Team
  • Manage medical information function/vendors to ensure written and verbal medical information on Seqirus’ products is provided to an acceptable quality standard and in a timely manner. Provides scientific expertise and oversight for response to escalated medical inquiries
  • Oversee and manages Regional Congress/Conference Planning: Preparation, On-Site Management and Post Conference debriefings
  • 4Develop and implement Medical Affairs processes, to ensure alignment with Global requirements, procedural documentation and systems. Ensures medical governance, including overseeing compliance with internal codes and pharmacovigilance regulations
  • Manage contracts with vendors to ensure service provided is compliant, meets agreed upon metrics and is cost-effective
  • Manage local processes with vendors to ensure accurate and timely capture of Spontaneous Adverse Events and reporting to Global Safety
  • Provide Regional support to Global Safety, for local/regional PV audits/inspections by Regulatory inspectors or partner audits as required
  • Provide Regional support to Global Safety to ensure local and regional Pharmacovigilance Agreements are implemented and monitored

Principal Accountabilities:

  • Drive functional and operational excellence in the strategic development and effective use of medical and scientific information for Seqirus products and disease areas. Ensure alignment of scientific messages/content between Regional and Global Medical Affairs. Develop strategic scientific exchange materials, content for medical meetings/Symposia, Advisory Board materials, and content for internal Medical Affairs staff training. Plans, directs and tracks operational and financial expenses and monitors regional MA budget. Prepares Regional Medical Affairs monthly reports.
  • reports and uses business insights to enhance existing responses, create new responses where needed, retrain staff, as well as ensuring alignment with strategic direction. Streamline processes for unified responses among products and countries within the region.
  • This includes the development of training materials, the delivery of regular and ad-hoc training, and the monitoring of training compliance.
  • In collaboration with other functions, develop and implement Medical Affairs SOPs to which are compliant with medical policies and safety requirements for the local/regional business. Ensure patient programs, post-authorization studies, or any other activity/initiative that may involve handling/receipt of any safety information are compliant with local/regional safety and global Safety requirements. Create and implement AE and PTC handling and reporting processes for all products in the region.
  • Ensure Medical Affairs function is audit-ready. Work with Med Affairs team, vendors, CQA, Global Safety to ensure local/regional business units are well-prepared for partner company audits and regulatory inspections. Ensure CAPAs impacting local/regional Medical Affairs departments and med info vendors are completed within agreed timelines.
  • This includes the development of training materials, the delivery of regular and ad-hoc training, and the monitoring of training compliance.
  • Key Medical Communications contact and resource to internal associates/groups regarding product and therapeutic area; create and provide trainings (sales, NAMs, vendors). Is a resource to other colleagues; provides guidance within Medical Affairs.

Scope/Accountability:

  • Set direction for the Medical Information function and engender a culture of accountability, continuous improvement and customer service
  • Ensure regional and local medical information and pharmacovigilance processes are in line with local and regional safety requirement and Global Safety policies
  • Ensure Regional Medical Affairs is audit ready
  • Ensure local/regional staff appropriately trained and medical and PV training delivered.
  • Ensure medical information is accurate, scientifically balanced and timely responses to inquiries are given to health care professionals, consumers and other customers; create, oversee and monitor responses provided by vendor
  • Impact/Influence/Liaison:
  • Ensure medical information vendor/function is managing medical enquiries in accordance to agreed metrics
  • Responsible for AE reporting training in the region
  • Key interface between Global Safety and Commercial Operations/Medical Affairs on PV matters
  • Key resource and supports Seqirus for all regional medical information among internal/external customers
  • Ensures Med Affairs processes are compliant with company policies and local/regional requirements
  • Provide employees with training and resources to meet/exceed customer requirements
  • Audit performance ratings
  • Monitors processes to identify continuous improvement opportunities
  • Lead medical information processes from a global perspective and provide a consultative role to other regions to improve processes

Key Relationships:

  • Seqirus Medical Affairs Team
  • Medical information vendors
  • Seqirus Global Safety
  • Regulatory Affairs, Clinical teams
  • Commercial Operations: Marketing, Sales, Health Economics
  • CQA and Quality
  • Manufacturing
  • Public Affairs/Corporate Communications
  • Legal
  • External experts
  • Customer service
  • Policy group

Education/ Experience Requirements:

  • A degree in life science or medicine
  • Specific expertise in Medical Information, Quality, Regulatory Affairs or Pharmacovigilance is of particular advantage
  • Minimum 10 years’ experience of medical information experience in the pharmaceutical industry
  • Extensive knowledge of regional and local regulatory requirements
  • Knowledge and understanding of medical information processes
  • Knowledge and understanding of PV obligations

 

Seqirus is an Equal Opportunity Employer and takes pride in maintaining a diverse environment. We do not discriminate in recruitment, hiring, training, promotion or any other employment practices for reasons of race, color, religion, gender, national origin, age, sexual orientation, marital or veteran status, disability, or any other legally protected status.

 

 

 


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