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Title: Business Analyst

Location: 351 North Sumneytown Pike, North Wales, PA

Pharmaceutical /CMC Background is highly preferred.

Qualifications:

We are seeking two skilled Technical Business Analyst to play a vital role in our Chemistry, Manufacturing, and Controls (CMC) operations team.

The ideal candidate will support the Strategic Operation leads and collaborate with various stakeholders to gather, analyze, and document business requirements for systems and dashboard implementation and enhancements.

They will work closely with the CMC Operations team and IT teams to translate these requirements into technical specifications, ensuring that the developed solutions align with operational needs.

This requires their ability to communicate effectively with stakeholders will be essential, as they will participate in meetings and workshops to clarify team objectives and serve as a point of contact for any inquiries.

We are looking to onboard in December 2024 and then have contractor support for the full year 2025.

For the location, US remote is acceptable but having contractors able to attend ad-hoc meetings in Upper Gwynedd, PA would be preferred.

Education: Minimum Bachelors Required Technical skills: ME office Suite, Veeva Vault , Power Bi , Dashboard

Years of Experience: 6-8 Pharmaceutical / CMC Background is highly preferred . Exp. with System Implementation and change management

Responsibilities:

• Requirements Gathering: Collaborate with stakeholders in CMC operations to gather, analyze, and document business requirements for new system implementations and enhancements.

• Technical Analysis: Translate business requirements into technical specifications, working closely with IT teams to design and develop solutions that meet operational needs.

• Documentation: Create and maintain comprehensive documentation including business requirements documents (BRDs), functional requirements documents (FRDs), process flows, and use cases.

• Stakeholder Communication: Facilitate meetings and workshops with stakeholders to ensure clear understanding of project objectives and requirements. Serve as the primary point of contact for any questions or concerns.

• Testing and Validation: Develop and execute test plans, test cases, and user acceptance testing (UAT) scenarios to ensure that IT solutions meet business needs.

• Requirements Gathering: Collaborate with stakeholders in CMC operations to gather, analyze, and document business requirements for new system implementations and enhancements.

• System Implementation: Oversee the planning and execution of new system startups, including coordinating efforts between cross-functional teams (e.g., Quality Assurance, Regulatory Affairs, and IT).

• Process Optimization: Assess existing CMC processes and systems, identifying areas for improvement and recommending innovative solutions to enhance efficiency and compliance.

• Data Management: Collaborate with CMC Ops Strategic Lead to define data requirements, and drive data integrity efforts in CMC systems.

• Successfully engage in multiple initiatives simultaneously • Work independently with users to define concepts and under direction of project managers

• Drive and challenge business units on their assumptions of how they will successfully execute their plans

• Strong analytical skills required, including a thorough understanding of how to interpret business needs and translate them into application and operational requirements.

• Serves as the conduit between the internal customer community and the software development team through which requirements flow.

• Develop requirements specifications according to standard templates, using natural language.

• Collaborate with developers and subject matter experts to establish the technical vision and analyze tradeoffs between usability and performance needs. Be the liaison between the business units, technology teams and support teams.
If interested; kindly share your resume with answers: 
Q1- How many years of exp in Pharmaceutical /CMC Background
Q2- How many years of exp as IT Business analyst in Pharmaceutical /Chemistry, Manufacturing, and Controls 
Q3: How many years of exp in gather, analyze, and document business requirements for systems and dashboard implementation and enhancements.
Q4: Have you worked iwth CMC Operations team and IT teams to translate these requirements into technical specifications, ensuring that the developed solutions align with operational needs.
Q5: how many years of exp in ME office Suite, Veeva Vault , Power Bi , Dashboard
Q6: How far you live from and how will you commute daily 351 North Sumneytown Pike , North Wales, PA