| Location | Cambridge, MA |
Duration: 6 month
Objective
Provide process-development expertise and operational delivery support for assigned Clinical Trial Delivery and Pharmacovigilance initiatives.
Develop process maps, RACIs, procedures, work instructions, job aids, and related implementation materials based on approved requirements and stakeholder input.
Facilitate workshops, stakeholder interviews, documentation activities, and project tracking to support effective and compliant ways of working.
Partner with accountable stakeholders, who retain process ownership, prioritization, governance, decision-making, and final approval responsibilities.
Accountability
Partner with accountable stakeholders to execute assigned process-development and improvement activities for CTD and PV initiatives.
Develop process content packages, including process maps, RACIs, procedures, work instructions, job aids, implementation materials, and other supporting documentation, as applicable.
Create and update Lucid process maps using approved requirements, existing documentation, and stakeholder input.
Facilitate cross-functional workshops and subject matter expert interviews to gather requirements, document process steps, clarify roles and handoffs, and confirm proposed content.
Draft and revise process documentation with document owners and subject matter experts in accordance with applicable quality and document-control requirements.
Coordinate activities for assigned PleaseReview workflows, including preparation of review packages, tracking comments, scheduling comment-reconciliation discussions, and maintaining review records.
Maintain project plans, status reports, action and decision logs, RAID logs, and deliverable trackers for assigned initiatives.
Identify and document risks, dependencies, unresolved questions, and required decisions for assigned initiatives.
Provide process-development expertise and recommendations within the assigned scope, escalating prioritization needs, complex decisions, governance matters, and items requiring final approval to accountable stakeholders.
Core Elements
Operational experience in Clinical Operations, Study Management, Data Management, and/or Pharmacovigilance; Global Regulatory Affairs experience is beneficial but not required.
Demonstrated experience translating complex operational requirements and existing documentation into clear process maps, RACIs, procedures, work instructions, job aids, and related process content.
Working knowledge of GxP quality systems, controlled-document practices, clinical trial and/or PV processes, and applicable regulatory expectations, including ICH GCP.
Experience facilitating cross-functional workshops and subject matter expert discussions to gather requirements, clarify roles and handoffs, and confirm proposed process content.
Ability to independently develop assigned deliverables within agreed requirements and scope.
Experience with process-mapping tools such as Lucid and document-review workflows such as PleaseReview is preferred.
Qualifications
Bachelor’s degree or international equivalent required; degree in life sciences or a related discipline preferred.
Six or more years of relevant experience in the pharmaceutical industry, biotechnology industry, or a clinical research organization.
Strong written and verbal communication, organization, facilitation, interpersonal, conflict-resolution, and problem-solving skills.
Demonstrated ability to collaborate effectively in a global, cross-functional, and matrixed environment.
Ability to organize and manage multiple assigned deliverables, meet agreed timelines, and provide clear and timely status updates.
Ability to adapt to changing priorities, incorporate stakeholder feedback, and work independently within established scope and direction.
Global or international experience preferred, including the ability to collaborate with stakeholders across locations and time zones.
About US Tech Solutions: US Tech Solutions is a global staff augmentation firm providing a wide range of talent on-demand and total workforce solutions. To know more about US Tech Solutions, please visit www.ustechsolutions.com.
US Tech Solutions is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, colour, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.
AI Statement: By applying, you acknowledge that AI-assisted tools may be used during hiring.
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