Oferta pracy

Sr. Specialist, Regulatory Operations

Moderna Poland

Moderna Poland

rondo Daszyńskiego 1

Wola

Warszawa

Your responsibilities

The Role:

As part of the company’s unprecedented growth and expansion, Moderna is taking an important step in the evolution of the organization in building a world-class, international Global Business Services (GBS) center based in Warsaw, Poland. The Global Business Services center will house talent in Finance, Pharmacovigilance, HR, Digital, Compliance among many other functions as it builds a foundation for shared services, internationally.

The Senior Specialist, Regulatory Operations is responsible for entering and managing regulatory information in a Veeva RIM System. This individual will manage the creation of Commitments, Health Authority Questions, Regulatory Objectives, and Registrations on behalf of our Regulatory Strategists. The Specialist will also upload Correspondences, and other documents as needed.

Here’s What You’ll Do:

• Serve as senior team member and escalation point for local Regulatory Operations Specialists who provide central data processing for the Global Regulatory Sciences team, supporting the following processes:

o Archiving Health Authority Correspondences within Veeva RIM Library.

o Capture Health Authority Questions (HAQs) and generate Response Documents within Veeva RIM.

o Capture Commitments within Veeva RIM.

o Create and manage Registrations within Veeva RIM.

o Create and manage Regulatory Objectives within Veeva RIM.

o Provide ad hoc data entry requests in Veeva RIM.

• Work collaboratively with International Regulatory Operations to support the following international data processes:

o Manage IDMP data and submissions.

o Manage EudraVigilance product data.

• Monitor the data quality of the local Regulatory team’s work.

• Participate on special projects:

o Provide ad hoc data remediation as needed in Veeva RIM.

o Participate in system enhancement projects as needed.

o Provide end-user support as needed.

Our requirements

  • Bachelor’s degree in a scientific discipline or systems technology or equivalent with 5 years of pharmaceutical experience working in a regulated, life science

  • Higher degree in a scientific discipline or systems technology or equivalent with 3 years of pharmaceutical experience working in a regulated, life science environment (pharmaceutical, biotechnology, consumer health)

  • Knowledge EDMS technology, prefer VeevaRIM experience

  • Knowledge of SPOR, IDMP requirements.

  • A demonstrated ability to collaborate with groups globally and cross functionally (Regulatory, clinical, nonclinical, etc.)

  • Excellent English Language Skills - Strong written and verbal communication skills for communication to internal customers

  • Self-organizational skills and ability to balance multiple priorities in a dynamic environment

  • Ability to own/manage respective responsibilities and work with limited daily direction

  • Strong team player

  • A desire to be part of a high-growth, transformational company that is Bold, Relentless and Curious

  • Benefits

  • private medical care

  • employee referral program

  • extra leave

  • generous computer glasses and contact lens reimbursement

  • equity plan

  • well-being programs

  • 1 month paid sabbatical after 5 years

MODERNA MISSION:

Why we come to work every day?

MODERNA MISSION

Deliver on the promise of MRNA science to create a new generation of transformative medicines for patients.

About MIBS:

The brand new Moderna International Business Center is an exciting next step in our global expansion. Based in the heart of Warsaw, it provides our growing organization with innovative and strategic support to help scale our business for the benefit of people and patients around the world.

We offer an opportunities in Digital, Finance, Human Resources, Pharmacovigilance and Supply Chain.

Moderna Poland

Welcome to Moderna. We believe mRNA is the “software of life."

Every cell in the body uses mRNA to provide real-time instructions to make the proteins necessary to drive all aspects of biology, including in human health and disease.

Given its essential role, we believe mRNA could be used to create a new category of medicines with significant potential to improve the lives of patients.

We are pioneering a new class of medicines made of messenger RNA, or mRNA. The potential implications of using mRNA as a drug are significant and far-reaching and could meaningfully improve how medicines are discovered, developed and manufactured.

Since our founding in 2010, we have worked to build the industry's leading mRNA technology platform, the infrastructure to accelerate drug discovery and early development, a rapidly expanding pipeline, and a world-class team. Our pipeline includes development candidates for mRNA-based vaccines and therapies spanning several therapeutic areas, and we have multiple clinical trials underway with other development candidates progressing toward the clinic. In addition, we have numerous discovery programs advancing toward development.

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