Technical Writer/Project Manager

Hours Worked: Typically, Monday through Friday, forty-hours per week. However, must be flexible to meet the needs of the department and complete other projects as assigned.

Position Summary:

The Technical Writer/Project Manager (Tracking, Deviations & CAPA) serves in a key role providing project support across different functional areas (Operations, Customer Service, Quality, Facilities, & Compliance) by facilitating, authoring deviations for intracompany issues. This position will lead a weekly meeting with several departments reviewing, tracking and following up on deviation response times. The role is highly independent and will report to the manager providing input to enable progression on key initiatives.  

Duties and Responsibilities:

It is everyone’s responsibility to live out our Values and Absolutes

by Shaping a World of Trust while ensuring responsible progress.

• Collect, create, maintain and track progress of projects through visualization tools (example PowerBi, Excel, PowerPoint or Dashboards) to manage status and progression of defined project improvements/key initiatives.
• Gather, track and complete governance documents related to project improvements, department agendas and key initiatives across several department functions (progression of current and/or new additions).
• Author technical documents related to change management, intra-company issues with the use of systems such as Trackwise/Veeva Vault.
• As Document Controller/Editor ensure technical procedural revision review and approval workflows are achieved.
• Monitor, update and look for trends in documentation and reports related to clinical supply chain, clinical trial kit distribution, pharma labeling and device manufacturing (Regulatory, FDA, TSA or GMP environment)
• Lead team meetings to present projects progress, data and up action items (PowerPoint)
• Be the subject matter expert for deviations, procedure and technical documentation progress and tracking
• Follow the guidelines set forth with clients and in the Bureau Veritas Consumer Products Services, Inc Quality, Health, Safety, Security and Environmental policies and procedures.
• Comply with clients and Bureau Veritas Consumer Products Services, Inc management systems in accordance with appropriate regulatory agencies.
• Other duties as defined by manager, department needs and workload.

Skills & Proficiencies:

• Strong organizing/multi-tasking skills, document tracking and naming conventions
• Strong clear communicator speaking in large groups
• High level of attention to detail
• Knowledge of documentation control and practice
• Ability to lead meetings (PowerPoint), present and collect data as well as follow up action items
• Ability to get along with others with excellent interpersonal communication and networking skills
• Demonstrated strong written and verbal communication skills
• Ability to work well in a team environment and resolve issues quickly
• Proficiency with computer systems for example PowerBi, PowerPoint, Tableau, Trackwise, Excel, Veeva Vault etc.
• Positive attitude
• Adheres to Company Values

Education and Experience:

• Degree requirement: Bachelor's Degree in related field

• Minimum of three (3) years of experience in regulatory environment

An equivalent combination of education and experience may be accepted in lieu of above.