Project Manager I (Clinical Document Operations) – Serbia Remote Based – Medical Writing
Location: Serbia (Remote Based)
Job Responsibilities
- 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.
Summary
Ensures the contracted services and expectations of a regulatory and/or medical writing project are carried out by the Company project team in accordance with the executed contract and the Customer’s expectations. Works in the role of a project manager on assigned project(s), which may range from single service to large full scope multi-year. Duties include primary liaison with Customers, Functional leads, Vendors, and Senior Management.
Additional Information
Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.
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