Senior IDMP Consultant

I am seeking a an experienced IDMP consultant to provide consulting and implementation support for IDMP projects

ROLE: Provide consulting and implementation support for IDMP projects

INDUSTRY: Senior IDMP Consultant

LOCATION: Germany

SALARY RANGE: Up to 85.000EUR

RESPONSIBILITIES: To Provide consulting and implementation support for IDMP projects

• Help define the requirements for IDMP data Collection, Compilation and Migration strategy
• Help define the overall business strategy and plan for executing IDMP submissions
• Establish overall IDMP data governance
• Coordinate with client stakeholders and internal team in driving project related activities
• Establish a process flow ensuring all steps involved in IDMP submission are followed
• Define the process for maintaining data in Data collection repository, including XEVMPD related data changes, and updates to IDMP data
• Work directly with different stakeholders like local country SPOC (Single Point of Contact), business SPOC from RA, PV, RIMS, R&D, GMS (Global Medical Safety), Marketing, Labeling etc. and any third party vendors to procure IDMP data and for managing changes to existing data in Data Collection Repository
• Act as a primary point of contact for all Data maintenance and Change Management activities
• Prepare and implement standard excel templates for collecting any changes to data from various functional groups
• Author detailed IDMP Process SOPs, work instructions, manuals, training guides with contribution from other stakeholders
• Perform impact analysis of data already collected whenever the Isi Technical standards and / or EMA IDMP guidelines are available
• Analyse and prepare a plan for implementation of IDMP guidelines
• Generate operational reports as appropriate and conduct project review meetings with core project team

• Be a business analyst and subject matter expert to identify and document RIM related user requirements and use cases in collaboration with cross-functional stakeholders
• Develop procedure documents or best practices for RIM, implementing and managing RIM governance
• Be a business partner to provide application support for future and existing RIM systems
• Be responsible for RIM technology solution identification, insights into new regulations, requirements, guidance and specifications relevant to RIM technology
• Monitor, analyse and track new functionality of new RIM releases and implement in collaboration with GIS, vendors and cross-functional key business stakeholders
• Assist in audit and inspection activities including retrieval of Regulatory Information
• Strengthen our team with developing and execution of RIM-specific training on how to effectively access Regulatory information
• Support presales and solutioning activities for Regulatory Information management System (RIMS)
• Develop and maintain project metrics used to be used for project status review.

REQUIREMENTS:

• Regulatory Information Management work and consulting Experience
• XEVMPD Consulting
• IDMP knowledge & Consulting experience
• Industry RIMS applications experience (e.g. Aris Register, Liquent Insight, CuneRIM etc.)

If this sounds interesting, and you fit the requirement, then please get in touch by sending across your updated CV to me, Raymond Martin :Email: R.Martin@nonstop-recruitment.com

Or give me a call on:
Phone: +49 892 109 3363
Internal Extension: 3490

I look forward to speaking with you soon! NonStop offers a referral incentive to anybody who introduces us to a successfully placed candidate. Should you know someone who would be a great fit for this, or any other regulatory affairs role, then feel free to drop me an email for more details on this.

NonStop is one of the largest and fastest growing specialised life sciences recruitment companies in Europe. We are proud members of the APSCo life sciences group who ensure we meet the highest quality standards within the recruitment industry. Our offices are located in the UK, Luxembourg, Switzerland, Romania, the US and the Czech Republic and we hold labour leasing licences across Europe. Please visit our website for a full list of the niche markets we cover