Job Description

MEDICAL OPERATIONS ASSOCIATE - SINGAPORE (12-month contract)

Do you have expertise in, and passion for, Medical Operations and Pharmacovigilance? Would you like to apply your expertise to impact the lives of patients in a company that follows the science and turns ideas into life changing medicines? Then AstraZeneca might be the one for you!

ABOUT ASTRAZENECA

AstraZeneca is a global, science-led, patient-focused biopharmaceutical company that focuses on the discovery, development and commercialisation of prescription medicines for some of the world's most serious diseases. But we're more than one of the world's leading pharmaceutical companies. We are on a journey to bring life-saving medicines to patients. Our role in contributing to decreasing mortality rates globally is clear - shaping the future by spotting a scientifically-led commercial opportunity and acting now to operationalise and scale it.

Our Singapore Marketing Company (SGMC) is responsible for the marketing of our medicines in Singapore. Here you'll also find colleagues from AstraZeneca's corporate functions and our Asia and International regions' sales and marketing teams. As a member of the Singapore Association of Pharmaceutical Industries (SAPI), all of our sales, marketing and communications activities are subject to the SAPI Code of Conduct.

BUSINESS AREA - Singapore Marketing Company, Medical Affairs

At AstraZeneca we fuse the worlds of Medical and Commercial to spot opportunities and pioneer approaches that better serve our patients.

Bridging Commercial and Scientific goals, we apply our people and leadership skills to launch cutting-edge products into our growing healthcare ecosystem. It takes a holistic mindset to treat each unique patient and tailor the whole experience - from early diagnosis to treatment.

With a strong foundation of science and ethics, we run fast but never compromise on doing the right thing. Working at pace in our ever-changing, ambiguous markets takes creativity and imagination. We always feel supported to do this, learning from our failures and working as a team to win together.

What you'll do

You will be responsible for the performance Site Management & Monitoring (SMM) Clinical trials, IITs/ESRs and RWEs performance with the objectives of timely delivery of data which is compliant with AZ Procedural Documents, ICH-GCP and local regulations, and delivery of a study management service across clinical studies from study start up until publications/final study report. You will act as QPPV deputy and be accountable for AZ's compliance with prevailing regulatory requirements governing the conduct of pharmacovigilance, namely maintaining the AZ PV system as relevant for products approved in the marketing company, having oversight on the safety profiles and any emerging concerns in relation to the medicinal product for which AZ holds the marketing authorization in the marketing company.

SMM Responsibilities

• Works as part of a Medical Affairs team providing support, guidance and advice on a local level for study matters.
• Ensures the processes for study delivery are executed through the development of study reports.
• Has a keen understanding of the AZ processes and systems for the management of all trial related matters.
• Trains the medical team on the proper conduct of studies and audits the various trial management and conduct.
• Manages external approvals for all studies & the study drug supply for all trials/clinical studies.
• Works with local SMM study managers as appropriate to optimize the performance of the local study team(s) at country level.
• Perform clinical and operational feasibility assessment of potential studies to the highest quality. Contributes to site selection process by identifying potential sites/investigators
• Involves in submission or coordination of proper application/documents to Regulatory Authorities through-out the study activities and manage external approvals for all Studies
• Contributes to patient recruitment strategy including ad-hoc communication with participating Investigators as necessary.
• Develops existing tools and processes to identify areas of improvement and ensures business continuity for study delivery.
• Supports SMM in different local initiatives as agreed with the Medical Director and Country Head SMM.
• Optimising SMM efficiency with respect to local initiatives which enhance performance

ESR Responsibilities

• Coordinate and facilitate the LREG for all submitted ESR proposals, protocols, and protocol amendments
• Document LREG discussions and review outcomes, before uploading into the ESR Operations System (Attachments Tab)
• Document GREG discussions and review outcomes, before uploading into the ESR Operations System for protocol approval (Reviews Tab)
• Operational support for all ESR, ensuring compliance with all applicable Company policies, processes/procedures
• End user support and training in the ESR process and use of the ESR Operations System
• Collaborate with the MEOR/OBU Operations Team to ensure the performance and milestones of the ESR are periodically assessed to verify the Sponsor/Sponsor-Investigator is achieving the deliverables as outlined in the RA/MTA
• Responsible to archive all the study related documents from the LREG till Publications/Close-out in the ESR Operations System
• Coordinate the study drug supply for ESR/IITs.
• Supports audits and regulatory inspections, according to the company policies, as required
• Monitor the monthly ESR bulletin and follow-up on action items/Quarterly traffic lighting assessment with respective MA/MSL and PIs as required.
• Ensure with the medical contact that the study has been published appropriately

Real World Evidence Studies

• Provide guidance on regulatory and operational matters for the studies to be conducted in Singapore.
• Track the progress of all the studies and adherence to milestones
• Ensure with the medical contact that the study has been published appropriately

Deputy QPPV Responsibilities:

Oversight of the AZ PV system, being in a position to assure the following components:

• Awareness of any conditions or obligations and other commitments relating to safety or the safe use of the products.
• Ensure the conduct of PV and submission of all PV-related documents is in accordance with the marketing company requirements and Good Pharmacovigilance Practice (GVP).
• Ensure the necessary quality, including correctness and completeness, of PV data submitted to the local regulatory authority.
• Ensure a full and prompt response to any request from the local regulatory authority for the provision of additional information necessary for the benefit risk evaluation of a medicinal product.
• Provide input into the preparation of regulatory action in response to emerging safety concerns (e.g. variations, urgent safety restrictions, and communication to patients and healthcare professionals).
• Provide and disseminate key safety knowledge to Marketing Company personnel as required including but not limited to signal detection data, legal issues, key safety literature articles, local regulatory authority advisories.
• Disseminate Investigation Response Letter to the complainants for Product Quality complaints in absence of lead PSM. Act as delegate for Patient Safety Manager, as required.

This is a position on a 12-month contract and is not eligible for sponsorship of employment visa/work permit in Singapore.

Essential for the role

Bachelor's degree in relevant discipline

Experience of Study Management within a pharmaceutical or clinical background

Knowledge of relevant legislation and new developments in the area of Clinical Development and Study Management

Desirable for the role

Advanced degree within the field

Professional certification

Understanding of multiple aspects within Study Management

Pharmacovigilance 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?

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Date Posted 17-Oct-2022

Closing Date

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.