Regulatory Document Specialist - Waltham, MA | Biospace
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Regulatory Document Specialist

AstraZeneca Pharmaceuticals LP

Waltham, MA
Posted Date:
Position Type:
Full time
Job Code:
Required Education:
Bachelors Degree
Areas of Expertise Desired:

Job Description

Location: Waltham,
United States
Job reference: R-010691

Posted date: Aug. 18, 2017

Oncology Regulatory Document Specialist/Information Manager/Project Manager

Turn your in-depth understanding of the principles of the regulatory documentation processes and information management into a successful career implementing change and best practice within a world-leading pharmaceutical company. At AstraZeneca, we’re looking for a Regulatory Document Specialist with Compliance/Information Change experience to join us in Gatehouse Park, Waltham. You will work to ensure scientists are recording data in line with regulatory standards, identifying potential gaps with a view to ensuring submissions are successful.

AstraZeneca is a global, innovation-driven biopharmaceutical business that focuses on the discovery, development and commercialization 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. At AstraZeneca, we're proud to have a unique workplace culture that inspires innovation and collaboration. Here, employees are empowered to express diverse perspectives - and are made to feel valued, energized and rewarded for their ideas and creativity.

In the Oncology Innovative Medicines group (IMED) we are passionate about science and our focus on creating novel medicines for patients with cancer. Our vision is to redefine the cancer treatment paradigm, restore the lives of cancer patients and eliminate cancer as a cause of death. AstraZeneca’s Oncology IMED is a cross-functional group based in the UK and US, with the ability to discover and develop novel oncology small molecule drugs in partnership.

Main duties and responsibilities

You must be a team player, willing to follow Oncology guidance on submission documents, but also bring your knowledge and experience to the table. As an oncology IMED Document Specialist you will be responsible for nonclinical Primary Pharmacology reports and discussion/interactions with the Drug Safety Metabolism (DSM) Regulatory & Submission Management Group, ensuring that the ABS role covers pertinent work and responsibilities.

As the local ANGEL Business Support (ABS) you are the ANGEL expert and will be responsible for requesting ANGEL training for the Lead Bioscientist, as well as helping them set up their account and provide any additional training (Workflow, Submission, Report Authoring and Copy Right training to the Project submission authoring team). You are accountable for importing Oncology Reports and References into ANGEL as well as Formatting, HouseStyling, completing PDF SRS on all Oncology documents and approving the documents to the submission delivery timelines.

You’ll be responsible for initiating and implementing change, provide support, guidance and advice, to a diverse group of researchers in oncology bioscience and translational science teams. You’ll also work on developing existing tools and processes, identifying areas of improvement and keep up to date on best practices and opportunities to improve methodology for regulatory submissions.

This role will involve solving complex problems across a variety of projects and implementing change. You’ll also be responsible for the preparation, quality control and delivery of primary pharmacology reports and contributions to regulatory submissions for the oncology IMED in compliance with our formatting standards.

As an advocate for Global Oncology you need to have a strong voice to support Bench and Lead Bioscientists to ensure that systems and processes are harmonized across the US and UK, as well as the face of Oncology on these global teams. You must be a team player, willing to learn from other team members but also bring your knowledge and experience to the table so that once you know the processes, rules and SOPs for the systems you can make real contributions to the processes and promote roll-out changes. Information Management and application of Good Information Practices in the area of Information and Records Management are critical, you will be responsible for ensuring Oncology iScience are aware of, correctly interpreting and routinely following the Global Retention and Disposal (GRAD) Schedule.


Essential requirements

  • BSc in relevant discipline
  • Experience at the bench (developing assays, generating & analyzing data, recording work in a system of record and following Global Best Practices)
  • Experience with an ELN system (preferable PE CambridgeSoft), data analysis systems (preferable GeneData Screener and Excel/Prism) as well as experience with data visualization systems (preferably Certara D360, Tibco Spotfire and Excel visualizations/graphing
  • Experienced in ensuring data and information is recorded correctly
  • Experience of laboratory information management systems (LIMS) such as Electronic notebooks (ELN e.g. Cambridgesoft) and IT data management and query solutions such as D360 (Certara) and Spotfire (TIBCO)
  • Knowledge of the regulatory processes and compliance
  • Working in document management and publishing systems

Desirable requirements

  • Training experience in BioELN, GLS, GRAD, IBIS Test Generation
  • Experience of running parallel audits for BioELN, working with RDI to identify areas to enhance and simplify current data and information systems critical to R&DProfessional certification
  • Understanding of aspects of scientific project management
  • Experience of using regulatory document management and publishing tools such as Documentum or FirstDoc and eCTDXPress

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.