Job Description

Onsite in New haven, CT (4 days onsite weekly)

1 year contract

Responsibilities may include the following and other duties may be assigned.

• Plan, research, develop, and write medical device labeling, and manage labeling deliverables as part of cross-functional project teams under general supervision.

• Simultaneously manage up to two labeling updates and one small, new-product-introduction project that involves multiple labeling pieces.

• Understand and adhere to all quality management system documents and product commercialization procedures applicable to labeling development.

• Conducts interviews with various users and technical staff to gather data for documentation.

• Recommends formats responsive to technical and customer requirements.

• Assist in providing documentation for CAPAs, and departmental and business-unit audits.

• Contribute to time and cost estimates for labeling deliverables for project teams.

• Develop illustrations in cooperation with professional illustrators.

• Participate on department and business-unit initiatives.

• Oversee Engineering Change Order process for labeling.

• Coordinate translations and track the status of translations.

• Complete labeling proofs, develop documentation for regulatory submissions, and carry out other tasks as assigned.

Please confirm your top 3 skills sets required?

1. Strong collaboration, verbal/written communication skills, and technical writing core competencies.
2. Experience with various authoring tools (eg, InDesign, Framemaker, XML tools).
3. Experience in complex regulatory environments and robust quality processes.

Can you please confirm the 3 main responsibilities/day to day activities required for this role?

1. Update Instructions for Use to align with cross-functional feedback, standards compliance, and other inputs in alignment with Tech Comm and business quality processes.
2. Support approvals in PLM tools, facilitate translations requests, and support launch activities (electronic and hardcopy distribution activities, such as metadata information and print proofs).
3. Participate in project and team meetings and collaborate with teams to create, analyze, and finalize Instructions for Use from planning through launch.

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