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GDO Business Process Analyst

4 months ago

Harefield, United Kingdom Norgine Full time

ABOUT THE JOB

Want a 3D Career? Join Norgine.

At Norgine, our colleagues Dare themselves to be different and try new things, Drive to achieve their goals and beyond, and Develop themselves and their community.

We call it the 3D career at Norgine and it offers you a fully-rounded experience with no limits.

Bring everything about yourself that you’re proud of, whether that’s your passion for making a difference, focus on others’ well-being, or intellectual curiosity to unleash in a fast-paced environment and supportive community.

In return, get a sense of belonging, a long-term career with ongoing development and upskilling, and a company that cares about people’s wellness as much as you do.

Because at Norgine, we transform lives with innovative healthcare solutions.

We have an exciting opportunity for a GDO Business Process Analyst to join Norgine.

The person holding this position will report to the Director, Global Development Systems and Processes and be a member of the Global Development Operations Systems and Process team.

The core responsibility of the GDO Business Process Analyst is to work closely with other members of the Development Systems and Process Team. Business Process Analyst role is responsible for understanding the workings of Global Development Operations processes and systems to enhance and maintain them. This position will have direct daily contact with the global users, support their use of RIMS and work to optimize the business process.  The GDO Business Process Analyst will document, review and maintain Global Development Operations business processes and is required to make suggestions for simplification/improvements to current ways of working to enable more efficient and effective processes.

If you want a multi-dimensional 3D career in a leading healthcare organisation, join us.

 

KEY RESPONSIBILITIES INCLUDE BUT ARE NOT LIMITED TO:

•    Work closely with Global Development Operations to identify, analyse and improve core business processes and workflows.  Identify ways to utilise Veeva RIMS functionality to improve process efficiency

•  Work with stakeholders to identify, analyse and improve touchpoints with Global Development Operations processes and workflows.  Maintain GDO Process and Metrics tracking tools, ensuring connectivity between GDO and OSP processes

•   Lead / Participate in Global Development Operations project teams as required agreeing and delivering tasks in line with plans. Facilitate meetings and workshops with subject matter experts to document and analyse processes and workflows.

•   Evaluate and identify where process or system changes have impact on PSMF and provide input into the relevant sections of the PSMF.

•   Develop and maintain clear and detailed Global Development Operations process maps.  Partner with process owners and provide SME advice on best practice for process maps.

•   Develop strategy and oversee maintenance of  SOPs, Work Instructions and training materials which clearly describe processes and work flows.  Participate in GDO Continuous Improvement Committee, ensuring changes are implemented in the best way

•   Lead regular impact assessments of new system functionality, providing business process subject matter expertise and provide support and advice to stakeholders.  Partner with Development Systems and Process Team  members to determine configuration changes which should be adopted.

•   Prepare communications for GDO Systems and Process Team, ensuring messages to stakeholders are clear, consistent and timely.  Monitor GDO Systems Mailbox to ensure timely management of issues and queries.

•   Provide SME input to the development of UAT and PQ scripts, ensuring systems support Global Development Operations processes.

•   Ensure alignment between system and process by partnering with Development Systems and Process Team  members and business process owners to confirm that user requirements meet business process needs and propose new system functionality to improve processes.

•   Oversee and monitor training metrics for Global Development Operations.  Partner with GDO Compliance Manager to ensure compliant management and maintenance of training curriculums, tools and processes.

•   Develop strategy and oversee maintenance of  Global Development Operations user support materials, such as Veeva RIMS Core Training Materials, How To Videos, Knowledge Bank items, etc.

•   Monitor system and process forums for awareness of improvements or best practice that could benefit GDO.  Propose changes to GDOLT/Stakeholders to gain agreement to implement.

•   Carry out data collection, transformation and load activities as required, providing recommendations and advice to ensure compliance with defined business rules

•   Monitor the Development Systems and Process Team Support Request tool and resolving and/or escalating issues as appropriate

Requirements

JOB REQUIREMENTS:

•      General knowledge and understanding of pharmaceutical sciences including standardization and data management initiatives (Pharmacopeia, Standard Terms, ISO IDMP, EMA SPOR, etc)

•      Strong skills in Process Mapping, Business Process Reengineering and LEAN.  Able to efficiently and accurately document process and system requirements based on stakeholder discussions.

•      Strong analytical skills with a demonstrated ability to extensively analyse business processes, workflows and metrics

•      Strong understanding of MS Office Tools (Word, Excel, Project, PowerPoint, Visio), e-learning tools and regulatory tracking systems (Veeva Systems)

•      Capable of interpreting regulatory guidelines and applying them to validated computerized systems

•      Ability to simultaneously manage projects

 

EXPERIENCE

•      Bachelor’s degree in Computer Science, Business Administration, or related technical field or equivalent experience.

•      Solid experience as a Business Analyst with proven experience in a Global Development Operations role (Regulatory Operations, Pharmacovigilance) within the pharmaceutical industry

•      Leading and facilitating workshops and focus groups

•      Eliciting, documenting and developing business requirements

•      Developing instructional and procedural documentation and presentations

•      Hands-on experience administering validated systems such as:  electronic document management systems, regulatory tracking databases

•      Practical operational experience of working across disciplines and multiple regions/countries

 

Benefits

Our benefits may vary per location. Please liaise with the Norgine TA representative to obtain more information.

Sound good? Find out more about the career you’ll have with Norgine, then apply here.