Associate Science Submission Manager II
Location:
Gaithersburg , Maryland
Posted:
October 21, 2017
Reference:
R-014311
If you're inspired by the possibilities of science to change lives and you thrive when making brave decisions - join us.
MedImmune is the worldwide biologics research and development arm of AstraZeneca. Here, you'll have the opportunity to make a difference in people's lives every day. As one of the world's premier biotechnology companies, our mission is centered on delivering life-changing products that advance world health, and help fight and cure disease.  As Associate Science Submission Manager II in Gaithersburg, MD , you'll play a pivotal role in channeling our scientific capabilities to make a positive impact on changing patients' lives.
We're constantly pushing the boundaries of science to deliver life-changing medicines to patients, with a passion for discovery and a pipeline to show for it. We're pioneering innovative research and exploring novel pathways across key therapeutic areas including oncology, respiratory, inflammation and autoimmunity, cardiovascular and metabolic disease, and infection and vaccines. And we're industry-leading in immunology, protein engineering and translational science. We offer a unique and strong collaborative network as part of the AstraZeneca family, as together we explore synergies between small and large molecules.
MedImmune has a dynamic environment that fosters collaboration and innovation. We attract top minds, and we nurture and build top talent.
Main Duties and ResponsibilitiesAs Associate Science Submission Manager II , you will report to the Lead ANGEL Business Specialist.  You will provide operations support to the Science Submission Management (SSM) group and MEDI R&D Scientists in the following areas:  Generation, editing, compilation and quality control of regulatory submission documentation; Document formatting and PDF submission ready standard checks; Helpdesk and system administration support for ANGEL, eHive and CAP Administrator support as needed.
Additional operations support will include the following areas:
  • Within the regulatory document management system:
    • Generates quality and nonclinical basic structures and content for regulatory submissions. 
    • Ensures relevant regulatory-authority compliant document naming conventions are applied to components.
    • Imports and creates documents for regulatory submissions including referenced literature and reference lists
  • Edits submission documentation including:
    • Cross reference and update of reference list citations against in-text references
    • Creation of abbreviations list within documents
    • Creating intra-document and inter-document hyperlinks between documents that meet company submission ready standards
    • Formatting, conversion, or retyping of data tables using the Authoring Tool (MS Word, MS Excel)
  • Performs data QC for research reports and summary documents and within CTD modules
  • Formats, performs submission ready standard checks and converts quality and nonclinical submission documents to meet house-style and regulatory requirements.
  • With guidance provides ANGEL Helpdesk Support including:
    • Set up of product dictionaries within the document management system
    • Upload of templates into the document management system
    • Expert advice and troubleshooting of user issues
    • User group administration
  • With guidance, provides back-up eHive and CAP Administrator support for Scientists and SSM teams as needed.
    • Support issue of report templates and report identifiers as needed
    • Support review cycle and approval of reports
    • Provide administrative support within the report repository
Essential Requirements
  • Bachelor's degree or equivalent industry-relevant experience
  • Awareness of basic principles of GXP and ICH (International Conference on Harmonization)
  • Basic understanding of CTD (Common Technical Document) content.
  • Proficiency in Microsoft Office
  • Experience working within validated electronic document management systems
  • Familiarity with working within SharePoint
  • Good interpersonal skills and ability to build relationships to deliver a quality service
  • Strong communication skills with all levels of the organization, including Sr mgmt.
  • Ability to deal with ambiguity and changing priorities
  • Able to manage and prioritize activities with supervision
  • Good attention to detail
  • Able to follow written standards, procedures and processes
Desirable Requirements
  • 1-2 years of industry experience in validated electronic document management systems
  • Knowledge of the basic principles of the drug development process
  • Basic understanding of principles of CFR21 part 11 requirements and other global standards
  • Experience with Adobe Acrobat and related ISI tools (e.g. ISI toolbox)
Next Steps - Apply today!
To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them.
AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law. AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.

A little about us:
MedImmune is the global biologics research and development arm of AstraZeneca

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