Description
Essential Job Functions:
Coordinate project requirements, related field tasks and activities with the Project Manager and SME.
Create and maintain technical documentation for various products and services, including SOP, Work instructions, forms, etc.
Identify potential project risks and develop/implement strategies to minimize impact on project documentation timelines
Use automated documentation tools and processes to create and update documentation.
Work with product managers and engineers to gather requirements and ensure that documentation is accurate and up to date.
Proofread and edit documentation for clarity and accuracy.
Documentation System Management: Document control, versioning, archiving, and retrieval processes, to ensure efficient and compliant document handling.
Collaborate with other department and documentation SME to ensure that documentation is consistent across all products and services. Cross-Functional Collaboration: Collaborate closely with cross-functional teams, including Quality Assurance, Regulatory Affairs, Research and Development (R&D), and Manufacturing, to ensure alignment and consistency in documentation practices across departments
Respond to inquiries about documentation.
Participate in technical writing projects from start to finish.
Stay up to date on industry standards and best practices for technical documentation
Risk Management:
Proactively identify and mitigate risks related to documentation practices that could impact product quality, regulatory compliance, or consumer safety
Minimum Qualifications
Bachelor's degree in a relevant field (e.g., Chemistry, Biology, Regulatory Affairs) or minimum of [2 years] of experience in documentation management and compliance within medical devices, pharma or related industry
Strong attention to detail and analytical skills, with the ability to critically review and analyze complex documentation.
Excellent communication and interpersonal skills, with the ability to effectively train and collaborate with diverse teams.
Familiarity with electronic document management systems (eDMS), quality management systems (QMS), and Microsoft suite knowledge preferred.
Certification in Good Documentation Practices (GDP) or relevant areas is a plus.
Position Competencies:
Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists.
Ability to interpret feedback from non-skilled technical system users to uncover the source of problems and persistence to efficiently provide solutions.
Extreme attention to detail is required to ensure proper documentation of facts.
Ability to adapt well in the face of workplace stressors such as change in priorities, rush demands to complete documentation releases, maintaining the security of data, competing priorities of high significance to the successful function of the department.
Ability to multitask and prioritize assignments
Excellent customer service skills including strong problem solving and conflict resolution skills
Strong organizational skills
Other Requirements
A great attitude with the patience to teach and empower others
Ability to organize and present information clearly and concisely; excellent computer and keyboarding skills; high degree of prioritization skills
Strong organizational skills with a focus on follow up and follow through.
Ability to work with local and international teams
Ability to work on multiple projects, managing a broad range of tasks and prioritizing activities
Ability to influence peers and managers to ensure that objectives are met on time
Performs on-the-job training using tools, equipment, and materials trainees will use
Education: Bachelors Degree
Additional client information: