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Regulatory Documentation Manag...

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  • Company:
  • Location:
    Gaithersburg, MD
  • Job Type:
    Full Time Employee

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Regulatory Documentation Manager


"THERE ARE SEVERAL OPENINGS FOR THIS ROLE AND THE POSITIONS COULD BE A MANAGER OR SPECIALIST LEVEL (CL C OR CL D) BASED ON THE LEVEL OF EXPERIENCE AND EXPERTISE OF THE SELECTED CANDIDATE."

LocationMD, Gaithersburg
 or SWE, Molndal

 

Reporting to the Associate Director/ Group Manager, RDM, the Regulatory Documentation Manager (RDM) is responsible for working with Clinical and Regulatory to build and deliver the Clinical modules for eCTD submissions and monthly investigator updates (routine submissions) to the regulatory authorities (e.g., INDs, IND AEs, CTAs, MAAs, NDAs, sNDAs, Patient Safety documents, protocols, and drug shipments.)

RDM staff provide authoring support to Clinical Development staff and ensures all Clinical deliverables are published to agreed standards, often to challenging deadlines given the nature of safety and regulatory reporting requirements. 

RDM staff are experts in understanding regulatory authority requirements on technical/format aspects, for delivery of submissions worldwide. It is imperative that all deliverables meet the strict technical standards imposed upon the pharmaceutical industry by FDA, EMEA and other Health Authorities. 

Must have an in depth knowledge of relevant systems used for clinical information and submission handling.

Overall Responsibilities

  • Technical expert and specialist in Document Management Systems, providing guidance for the user community and ensuring regulatory documentation is retrievable, searchable and timely available.
  • As an integrated part of project and submission teams, provide submission management and regulatory documentation publishing expertise.
  • Expert in Health Authority standards and requirements, and continuously share knowledge within AstraZeneca.
  • Train and support authors globally to ensure technical quality is built into the document authoring process ensuring high standards of all regulatory documentation and submission components.
  • Participate and contribute to lessons learned (Study and Submission Teams) and share best practices globally within RDM.

Problem solving

  • Utilize the ANGEL ("A New Global Electronics Library") advanced search functionality to find relevant regulatory documents and submission life-cycle information to assist with litigation requests.

Impact on Business results

  • Monitor and act upon speed and quality standards to drive ongoing efficiencies in the clinical submission management process.
  • Act upon identified inefficiencies in up-stream processes.

Communication

  • Ability to communicate with senior management within the organization.

Functional Knowledge

  • The role holder requires a good knowledge of Clinical Development and Health Authority requirements to meet the business objectives and ensure compliance with regulatory authorities, quality and technical standards.

Specialist Skills

  • Utilize the ANGEL search functionality to find relevant regulatory documents and submission life-cycle information.

Business Knowledge

  • The role requires a good working knowledge of the pharmaceutical industry and Clinical Development.
  • The role holder will ensure that deliverables adhere to industry standards.

What is the global remit? (how many countries will the role operate in?)

  • Own country
  • Another country
  • 2 or 3 countries at a minimum of 40% of time


Essential
  • Expert knowledge of ANGEL/First Doc functionality, policies, procedures and processes.
  • University degree or equivalent experience.
  • Working experience of information management technologies, electronic publishing and/or have the ability to work in accordance to processes.
  • Demonstrated ability to work collaboratively in a team environment as well as independently.
  • Demonstrated ability to manage own priorities and goals.
  • Good English written and verbal communication skills.
Desirable
  • Experience of system administration for a validated application within a regulated environment.
  • Knowledge of the drug development process, product life-cycle, and contents/formatting of regulatory submissions.
  • Knowledge of AZ submission compilation, publishing, approval information processes, tools and standards.
Key Relationships to reach solutions
Internal (to AZ or team)
  • Business users across Regulatory and Clinical
  • Counterparts in other functions/business units
  • QA/QC
  • IS support staff
External (to AZ)
  • Not Applicable
Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled/Sexual Orientation

About Us? It's about you.

Choose a career in the company that will make a meaningful difference in your life. One that will forge a connection between you, those you work with, and the millions of patients across the globe who are the inspiration behind our passion.

We are AstraZeneca. More than 57,000 employees strong, we have a presence in over 100 countries across six continents. We represent a diverse gathering of cultures. Yet there is one element that connects us all: helping people live healthier lives.

Helping people live healthier lives in addition to... Embracing diverse perspectives. Working together to create a better future. These are the common bonds – the catalysts that inspire people to work here. So come here. Arrive knowing there exists the potential to make a real impact. Be among those who continue to make us an innovation-driven company that stands firmly among the world's leaders in biopharmaceuticals.

AstraZeneca does not accept non-solicited resumes or candidate submittals from search/recruiting agencies not already on AstraZeneca's approved agency list. Unsolicited resumes or candidate information submitted to AstraZeneca by search/recruiting agencies not already on AstraZeneca's approved agency list, and who were not asked to work on a specific vacancy, shall become the property of AstraZeneca and if the candidate is subsequently hired by AstraZeneca, AstraZeneca shall not owe any fee to the submitting agency.


Apply Online
http://bit.ly/VjJaqH

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