AbbVie Technical Writer-Author (Manufacturing Operations) in Worcester, Massachusetts
The Technical Writer-Author is the primary point of contact to provide change control execution for drugs, biologics, and medical devices. This role works across multiple functions to bring the appropriate individuals together to build robust change strategies that will be documented in the Change Management IT system (TrackWise).
What You’ll Do
Write change plans for operations required by manufacturing, engineering, and validation in support of manufacturing activities.
Drive alignment on individual change requirements, organization, and timelines for complex changes.
Facilitate Cross Functional Team meeting with individuals across the network to ensure change control documentation is accurate.
Respond to comments and questions from reviewers and approvers on changes owned.
Plan change timelines, execute change tasks in the system, and ensures due dates are confirmed with area SMEs to ensure timely completion.
Manage change control documentation review/approval and monitor open change plans and tasks to meet required timelines.
Open, monitor, and update fields of changes and tasks through the SolTRAQs quality system including Progress Change plans through the SolTRAQs Change Management system.
Recognize departmental gaps within a change control and follow up with area SMEs to fill those gaps.
Review change documentation with Regulatory bodies if the need arises and support regulatory audits as needed.
Accountable for compiling SME assessments, creating and assigning tasks, as well as the timely completion of change controls.
What You’ll Have
A degree with a minimum 3 years of technical writing related experience, preferably in the Medical Device or Pharma industry.
Knowledge regarding FDA regulations, ISO standards and ICH guidelines.
Ability to multi-task and navigate through changing priorities when needed.
Excellent organizational, interpersonal, presentation, and communication skills; Strong creative problem solving and analytical skills.
Experience working with TrackWise is preferred.
Project Management and support of marketed products experience is preferred.
What You’ll Receive
Comprehensive Healthcare: Medical, Vision, Dental, FSA, HSA
Financial Well-being, Planning & Stability: 401(k) with company match and Annual Retirement Contribution Plan
AbbVie Vitality: Health & Wellness programs including Employee Assistance Program (EAP), Health Advocate, Global Well-Being Programs
Generous Paid Time Off include, Company Holidays, Vacation, Parental and Caregiver Leave
Community Outreach Programs and company match of charitable contributions
Perks include AbbVie Product Shop, Employee Loyalty Program, Tuition Assistance, Adoption and Surrogacy Assistance, Mothers at Work and Milk Stork to list a few
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