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\xe2\x80\x99s most serious diseases. But we\xe2\x80\x99re more than one of the world\xe2\x80\x99s 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\xe2\x80\x99s sustainability goals in accordance with activities linked to HCPs interactions.

Managing audits.

Line management of Medical Governance/Nominated Signatory specialist.

What you\xe2\x80\x99ll 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 in-depth understanding of AZ disease areas, external MEA/GCC regulatory framework, applicable laws, and regulations in relation to the promotion of pharmaceutical products and the self-regulatory 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 cross-functional 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.

Up-to-date scientific knowledge and expertise

Practical understanding of pharmaceutical Code of Practice.

Excellence in cross-functional 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

3-5 years\xe2\x80\x99 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.

Only Candidates who are based in UAE will be considered.

Why AstraZeneca?

At AstraZeneca we\xe2\x80\x99re dedicated to being a Great Place to Work. Where you are empowered to push the boundaries of science and unleash your entrepreneurial spirit. There\xe2\x80\x99s 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\xe2\x80\x99re on an exciting journey to pioneer the future of healthcare.

So, what\xe2\x80\x99s next?

Are you already imagining yourself joining our team? Good, because we can\xe2\x80\x99t 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\xe2\x80\x99s yours.

Where can I find out more?

Our Social Media, Follow AstraZeneca on

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Date Posted 06-Jun-2023

Closing Date 16-Jun-2023

AstraZeneca embraces diversity and equality of opportunity. We are committed to building an inclusive and diverse team representing all backgrounds, with as wide a range of perspectives as possible, and harnessing industry-leading skills. We believe that the more inclusive we are, the better our work will be. We welcome and consider applications to join our team from all qualified candidates, regardless of their characteristics. We comply with all applicable laws and regulations on non-discrimination in employment (and recruitment), as well as work authorization and employment eligibility verification requirements.

AstraZeneca