Note: The job is a remote job and is open to candidates in USA. USDM Life Sciences is a consulting company that supports regulated life sciences organizations with GxP technologies and business processes. The Sr. Manager will provide process-development expertise and operational delivery support for Clinical Trial Delivery and Pharmacovigilance initiatives by developing process documentation, facilitating stakeholder workshops, and tracking project deliverables. The role partners with accountable stakeholders to support effective and compliant ways of working.
Responsibilities
- 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
- Performs other related duties and assignments as required
Skills
- Operational experience in Clinical Operations, Study Management, Data Management, and/or Pharmacovigilance
- 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
- 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
- Bachelor's degree or international equivalent required
- Prolonged periods of sitting or standing at a desk and working on a computer in an environmentally controlled home office environment
- Operate other office productivity machinery, such as a calculator, scanner, or printer
- Frequently communicate with stakeholders via telephone, email, or instant message. Must be able to exchange accurate information in these situations
- Global Regulatory Affairs experience is beneficial but not required
- Global or international experience preferred, including the ability to collaborate with stakeholders across locations and time zones
- Degree in life sciences or a related discipline preferred
Benefits
- Full-time employees are eligible for health, vision, and dental insurance, life insurance, short and long-term disability, hospital indemnity, accident, and critical care coverage.
- Both full and part-time employees, who are at least 21 years of age, are eligible to participate in USDM's 401k plan.
- Full and part-time employees may be eligible for paid time off.
- All employees are eligible for USDM's rewards and recognition program.
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