Work Schedule
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
Job Description
Thermo Fisher's clinical research business is a leading global contract research organization and world leader in serving science. We are passionate, deliberate, and driven by our mission - to enable our customers to make the world healthier, safer, and cleaner.
Within our Analytical Services team, we have a functional service provider solution, which is a unique partnership that allows our customers to demonstrate the experience of our staff, while allowing you, the employee, to gain direct experience working onsite at a pharmaceutical/ biopharmaceutical company, all while maintaining full-time benefits.
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Summarized Purpose:
As a Document Coordinator, you will contribute to internal and external development of the Client's specialty drug products and/or development of Strategic External Development's (SED)'s internal processes.
Essential Functions:
This role will provide you the opportunity to coordinate and support key product development activities while gaining knowledge of biopharma product development. These responsibilities include some of the following:
• Responsible for:
- Formatting documents per relevant SOP and/or job aid
- Uploading internal documents and/or 3rd party data into electronic document management system with required metadata (such as Veeva QualityDocs)
- Circulating documents for approval, and follow through to ensure timely approval
• Support the maintenance and tracking of SED Management Monitoring Program (MMP) and liaises with BPDS, PSC/SEM MMP specialists to ensure comprehensive oversight is facilitated
• Assist with the Sr Manager with tracking and following up with the implementation of control procedures, job aids and other documentation necessary for SED to operate, CAPAs, risks registers etc
• Assesses procedures for accuracy, simplicity, and practicality and influences changes as appropriate
• Assists/participates in preparation for and support of regulatory agency inspections, corporate and customer audits.
• Builds and maintains good working relationships with internal and external partners
• Performs data verification as necessary
• Manages issues and risks identified in area of responsibility.
Qualifications - External
Education and Experience:
High / Secondary school diploma or equivalent and relevant formal academic / vocational qualification
Technical positions may require a certificate
In some cases, an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role.
Knowledge, Skills and Abilities:
- Ability to focus on details.
- Critical thinking skills to identify and solve problems.
- Excellent oral and written communication skills for effectively interfacing with all levels of management and departments within the company and external partner sites.
- Strong organizational skills in order to maintain a high level of productivity and setting priorities in order to complete assignments in a timely manner.
- Exhibits high initiative, strong drive and follow-through.
- At least 1 year of GMP experience is strongly preferred
- Knowledge of and ability to use electronic Learning Management system (such as MyLearning), electronic document management systems (Veeva)
- Knowledge of GMP, Good Documentation Practices and pharmaceutical manufacturing
- Ability to manage databases of document owners, reviewers, approvers, authors and trending data
- Ability to coordinate documentation projects involving multiple documents and external partners
- Ability to influence, motivate and gain commitment without direct authority
- Works well with peers and all levels of management
- Displays strong leadership, facilitation, teamwork, networking, presentation, and planning skills
- Excellent verbal and written communication and interpersonal skills
- Exhibits high initiative, strong drive and follow-through.
- Effective organizational skills
- Good computer skills
- Strong attention to detail and problem solving skills
- Good written and verbal communication skills
- Ability to effectively conduct oral presentations
- Demonstrated experience in identification and resolution of technical problems in a professional environment
- Ability to attain, maintain and apply a working knowledge of applicable procedural documents
- Demonstrated positive attitude, enthusiasm toward work, and the ability to work well with others
As a condition of employment with PPD, part of Thermo Fisher Scientific, in this role, you must have received your Covid-19 vaccine and you must disclose proof of your vaccination status upon employment.