Project Manager I – Clinical Document Operations, Medical Writing

Role Overview

• Acts as a primary liaison between the Company and the Customer to ensure project launch, conduct, and closeout according to the Customer’s and Company’s contractual agreement.
• Ensures the project is progressing according to internal and Customer quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and International Conference on Harmonization (ICH) guidelines to fulfill all federal and local regulations.
• Providing support to coordination and governance activities related to acquisitions and divestment.
• Supporting the documentation of ClinDoc governance in collaboration with the hubs.
• Supporting the initiative to create materials and approach on Driving the Evolution of a Unified GxP ClinDoc Culture Toward Inspection‑Ready Excellence.
• Supporting the preparation of future onboarding toolkits content.
• May serve as the team leader by overseeing more junior project team members.
• Facilitates team building and communication.
• Acts as a liaison and facilitator between other departments within the Company for project related tasks and/or issues.
• Proactively monitors project resources and works with functional lead/management to ensure project requirements are met.
• Manages multiple projects ranging in size and complexity from single service regulatory/ medical writing projects to large full scope multi-year projects, global projects and/or programs, with minimal interaction from supervisor.
• This includes proactive operational and financial management of tasks, risk, escalations, and quality from start-up through final deliverable.
• Manages the executed contract and financial aspects of assigned projects/programs.
• Completes monthly review of tasks completed and backlog.
• Ensures customers are notified of out-of-scope items in a timely manner.
• Maintains effective communication with the Customer and project team through oral and written correspondence, project status reports, and monthly progress reports.
• Ensures adequate documentation of each communication.
• Independently prepares information for internal review meetings and proactively manages action resolution to ensure project delivery.
• Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools.
• Produces and distributes status and tracking reports as well as functional area plan, to appropriate team members and senior management.
• Networks to acquire new and/or repeat business.

Requirements

• Acts as a primary liaison between the Company and the Customer to ensure project launch, conduct, and closeout according to the Customer’s and Company’s contractual agreement.
• Ensures the project is progressing according to internal and Customer quality standards, Standard Operating Procedures (SOPs), Good Clinical Practices (GCPs), and International Conference on Harmonization (ICH) guidelines to fulfill all federal and local regulations.
• Providing support to coordination and governance activities related to acquisitions and divestment.
• Supporting the documentation of ClinDoc governance in collaboration with the hubs.
• Supporting the initiative to create materials and approach on Driving the Evolution of a Unified GxP ClinDoc Culture Toward Inspection‑Ready Excellence.
• Supporting the preparation of future onboarding toolkits content.
• May serve as the team leader by overseeing more junior project team members.
• Facilitates team building and communication.
• Acts as a liaison and facilitator between other departments within the Company for project related tasks and/or issues.
• Proactively monitors project resources and works with functional lead/management to ensure project requirements are met.
• Manages multiple projects ranging in size and complexity from single service regulatory/ medical writing projects to large full scope multi-year projects, global projects and/or programs, with minimal interaction from supervisor.
• This includes proactive operational and financial management of tasks, risk, escalations, and quality from start-up through final deliverable.
• Manages the executed contract and financial aspects of assigned projects/programs.
• Completes monthly review of tasks completed and backlog.
• Ensures customers are notified of out-of-scope items in a timely manner.
• Maintains effective communication with the Customer and project team through oral and written correspondence, project status reports, and monthly progress reports.
• Ensures adequate documentation of each communication.
• Independently prepares information for internal review meetings and proactively manages action resolution to ensure project delivery.
• Maintains and evaluates project progress by maintaining timelines and other tracking/analysis tools.
• Produces and distributes status and tracking reports as well as functional area plan, to appropriate team members and senior management.
• Networks to acquire new and/or repeat business.

Benefits

• We are passionate about developing our people, through career development and progression; supportive and engaged line management; technical and therapeutic area training; peer recognition and total rewards program.
• We are committed to building an inclusive culture – where you can authentically be yourself.