FSP- Lab Data Associate

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.

Summarized Purpose :

As a Document Coordinator, you will contribute to internal and external development of the Client's specialty drug products and / or development ofStrategic 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.