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Global Development Associate Medical Director II

Lieu Bangalore, Karnataka, Inde Job ID R-121078 Date de publication 11/01/2021

TITTLE – Global Development Associate Medical Director II

GCL – E

Apply your expertise to impact patients and ultimately save lives

Do you have expertise in, and passion for pharmaceutical medicine and  respiratory disease area? Would you like to apply your expertise in a company that follows the science and turns ideas into life changing medicines? If so, AstraZeneca might be the one for you!

The role will be focused on respiratory inhaled products so experience in this area is crucial.


ABOUT 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. Always committed to lifelong learning, growth and development

ABOUT THE TEAM
We’re a team of leading specialists, driven to pursue scientific knowledge. And there’s no better place to learn – from the science, from each other and from our failures.

It’s a dual role as we work on both understanding our patients better and contributing to scientific research. We are always learning from people who live with the diseases our medicines treat. So we can make sure that great science born in the lab can make a real difference to their lives.

Job Description / Capsule

Provides medical input to all aspects of product maintenance/license- to- operate activities in the respiratory area, such as periodic reporting, license renewals and responses to external requests including regulatory requests. Operating according to the highest ethical standards in compliance with internal SOPs, local regulations, laws and adherence to Good Clinical Practice and regulatory requirements.

Typical Accountabilities

  • Is responsible for medical/  Late-stage Development, Respiratory & Immunology (R&I) components of periodic reports such as Periodic Safety Update Reports (PSURs)/Periodic Benefit Risk Evaluation Reports (PBRERs) and annual New Drug Application (NDA) reports, license renewals, labelling and regulatory responses    (in collaboration with other team members) under the direction of the Global Clinical Head (GCH) or delegate Global Clinical Program Lead (GCPL)

  • Works with international colleagues and with external Alliance partners on regulatory requests/issues

  • Applies strategic intent of AstraZeneca when working with Alliance partners and Regulatory Authorities

  • Able to serve as a source of medical expertise for the Product Team

  • Able to provide guidance for investigator-initiated trials in cooperation with regional marketing companies 

  • Able to act as Global Clinical Leader delegate on assigned tasks.

  • Is accountable to GCH (or delegate) and Late-Stage Development, R&I leadership for identifying risks and proposing mitigation strategies to enable a successful execution of License-to-Operate tactics

  • Ensures consistent practices with the highest ethical standards in compliance with internal SOPs, local regulations, and laws

Education, Qualifications, Skills and Experience

Essential

Minimum Requirements

  • Graduate of a recognized school of medicine with an M.B.B.S., M.D. degree or equivalent.

  • The role will currently  be focused on respiratory inhaled products so experience in this area is crucial.

  • Fluent in oral and written English

  • 3 years clinical research expertise in relevant therapy area or CRO experience

  • Good knowledge of biostatistics, global regulatory environment and pharmacovigilance

  • Proven teamwork and collaboration skills

  • Good presentation skills. Can communicate effectively with internal and external collaborators

Desirable

  • PhD in scientific discipline

  • Education in Pharmaceutical Medicine

  • Specialty training in respiratory medicine or immunology is preferred, though well qualified candidates with demonstrated experience in other relevant therapeutic areas may be considered for the position

  • Experience from different organizations

  • An understanding of pharmaceutical industry R&D, particularly of major clinical milestones and of the factors which influence Drug development.

  • An understanding of the interplay between clinical, commercial objectives, drug safety and regulatory requirements

A clear demonstration of behaviours of

  • Demonstrated leadership qualities with particular focus on collaborative working skills, trust and openness, irrespective of cultural setting

  • Demonstrates AstraZeneca values and Behaviours

  • Agile responsiveness to scientific data. Credible in scientific and commercial environments

WHY JOIN US ?
This is a place of opportunity with the support you need to thrive and grow. You can move around, try different areas and develop new skills.
Most importantly, we get to work on lifechanging medicines for people who face serious conditions. Our innovative discoveries will ultimately have the potential to reach billions of patients’ in need across the globe. That’s why we love it – this is the place to make a greater impact

SO, WHAT’S NEXT?
Are you already envisioning yourself joining our team? Good, because we’d love to hear from you! Click the link to apply and we’ll be in touch as soon as we can.

WHERE CAN I FIND OUT MORE?
Our Social Media, Follow AstraZeneca on LinkedIn https://www.linkedin.com/company/1603/
We are an equal opportunity employer and value diversity at our company. We do not discriminate on the basis of race, religion, color, national origin, sex, gender, gender expression, sexual orientation, age, marital status, veteran status, or disability status.



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 authorisation and employment eligibility verification requirements.

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