Technical Writer, Quality Compliance

Technical Writer, Quality Compliance

Joining us is a chance to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, our colleagues are challenging what's possible and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care.

Summary Description

The Technical Writer, Quality Compliance is a key member of the Enterprise Compliance Master Plan (ECMP) Team with responsibility to support the Workstream (WS) Leaders by drafting future-state procedural documentation based on the outputs from the applicable ECMP phases, events and regulatory requirements; gathering and reviewing site-level procedural documentation; supporting in-person ECMP and WS-centric events; completing any necessary ECMP forms to capture outputs and outcomes for applicable ECMP phases and meetings; coordinating and routing ECMP related and ECMP WS Output documentation for approval; and reviewing and verifying accuracy and completeness of documents.

Essential Duties And Responsibilities

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily including their overarching responsibility of supporting the ECMP WS Leaders, including:

• Drafting future-state procedural documentation based on the outputs from the applicable ECMP phases, events and regulatory requirements;
• Gathering and reviewing site-level procedural documentation;
• Supporting in-person ECMP and WS-centric events;
• Completing any necessary ECMP forms to capture outputs and outcomes for applicable ECMP phases and meetings;
• Reviewing and verifying accuracy and completeness of documents;
• Coordinating and routing ECMP related and ECMP WS Output documentation for approval; and,
• Other duties as assigned.

Desired Minimum Qualifications

Education:

• Bachelor's degree is required.

Skills/Knowledge:

• 8+ years of experience in technical writing is required, or equivalent, i.e. Master's degree with 5+ years of experience.
• Experience in medical device, pharmaceutical and / or biotechnology industries is required.
• Experience in working within compliance frameworks such as FDA, ISO 13485, and EU MDR is required.
• Advanced technical writing, presentation, bibliographic research and editorial skills are required.
• Strong ability to interpret and disseminate relevant product information is required.
• Strong organizational skills, attention to detail and proofreading skills are required.
• Demonstrated project management skills are required.
• The ability to produce procedures, reports and documents independently and evaluate the writing of others is required.
• The ability to rapidly develop expertise in the company's internal document management system is required.
• Experience with Electronic Documentation Management Systems and Electronic Approval Systems is required.
• Being comfortable leading teams and educating team members as needed during process of document development is required.
• Ability to travel up to 40% if needed based on ECMP Workstream needs.

Physical Requirements

The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.