Quality Nominated Signatory Manager

2 weeks ago

Dubai, Dubai, United Arab Emirates AstraZeneca Full time

JOB TITLE
Quality Nominated Signatory Manager

ABOUT ASTRAZENECA


AstraZeneca is a global, science-led, patient-focused biopharmaceutical company focusing on discovering, developing, and commercializing prescription medicines for some of the world's most serious diseases.

But we're more than one of the world's leading pharmaceutical companies.

ROLE SUMMARY


The role of Medical Governance /Nominated Signatory covers a set of responsibilities for final approval of specified materials and activities linked to promotion, interactions with Health Care Professionals and Organisations, and other related areas such as non-promotional health education materials, donations, and HCPs administration.

This is an important responsibility and oversight role undertaken on behalf of the company.

  • Establish a comprehensive understanding of AZ business policies, procedures, and guidance such as that on product promotion and scientific exchange of information regulations.
  • Maintain an understanding of relevant legislation and external codes of practice relating to promotional activities.
  • Review GCC activities (Ethical interactions with HCPs & HCOs) in a timely manner via varieties of approval systems as per the AZ code of conduct & local SOPs.
  • Managing AstraZeneca's sustainability goals in accordance with activities linked to HCPs interactions.
  • Managing audits.
  • Line management of Medical Governance/Nominated Signatory specialist.

What you'll do


Review and approval typically involve a team approach where the Nominated Signatory Manager takes the final decision-making position after carefully considering input from Medical, Legal, Compliance, and Regulatory review and their personal, and professional expertise.


  • Grow an indepth understanding of AZ disease areas, external MEA/GCC regulatory framework, applicable laws, and regulations in relation to the promotion of pharmaceutical products and the selfregulatory framework of the pharmaceutical industry in MEA/GCC.
  • Support delivery of the Medical and Scientific Affairs strategy and business strategy plans across AstraZeneca TAs
  • Integrated business partner to the crossfunctional team in an aligned disease/therapy area
  • Provide strategic advice to CFT during the preparation/review of promotional/nonpromotional materials.
  • Proceeds for reviewing process for activities submitted via applicable systems from sales/marketing/medical.
  • Perform SOPs training for newly joined staff & refreshment training when appropriate.
  • Enhance compliance understanding within the organization.
  • Perform monitoring for GCC activities to ensure the following/ proper implementation of GCC ethical interactions SOPs.
  • Review and maintain continuous improvement of all processes with local GCC SOPs.
  • Work closely with a regional quality team to ensure coordination between GCC and MEA on GXP matters.

Essential for the role

  • Should have a degree in medicine, pharmacy, pharmacology, or other relevant life sciences.
  • Uptodate scientific knowledge and expertise
  • Practical understanding of pharmaceutical Code of Practice.
  • Excellence in crossfunctional working and collaboration with colleagues across wide range of teams.
  • Critical thinking skills and the ability to think strategically.
  • Effective communication and presentation skills.
  • Business acumen/ entrepreneurship; seek out opportunities and new ways of working.

Desirable for the role

  • 35 years' Experience in Quality, Nominated signatory, and Regulatory roles in the pharmaceutical industry.
  • Working knowledge in at least one of the disease/therapy areas of AstraZeneca.
  • A comprehensive understanding of pharmaceutical industry business policies, procedures, and guidance such as that on product promotion and scientific exchange of information regulations.
  • An understanding of commercialization processes/marketing activities and needs surrounding the effective promotion of drug products.
  • Media and digital channel nominated signatory experience.

Why AstraZeneca?
At AstraZeneca we're dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There's no better place to make a difference to medicine, patients, and society. An inclusive culture that champions diversity and collaboration, and always committed to lifelong learning, growth, and development. We're on an exciting journey to pioneer the future of healthcare.

So, what's next?

  • Are you already imagining yourself joining our team? Good, because we can't wait to hear from you.
  • Are you ready to bring new ideas and fresh thinking to the table? Brilliant We have one seat available, and we hope it's yours.

Where can I find out more?
Our Social Media, Follow AstraZeneca on LinkedIn

Follow AstraZeneca on Facebook

Follow AstraZeneca on Instagram

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