Engineering – Technical Writer

Planet Pharma; North Haven (CT); On-site; USD 70,000 - 110,000; Full time

Job summary

Planet Pharma is seeking a labeling specialist to plan, research, develop, and write medical device labeling and manage labeling deliverables across projects. You will oversee multiple updates, coordinate translations, and ensure compliance with quality systems and regulatory submissions.

This role requires a University Degree and at least 5 years of relevant experience, or an advanced degree with 2 years. You will work with cross-functional teams to meet project milestones and deliverables.

Qualifications

• Requires University Degree with 5+ years of relevant experience, or advanced degree with 2 years.
• Experience in labeling development for medical devices is preferred.
• Ability to work in cross-functional project teams and manage multiple updates.

Responsibilities

• Plan, research, develop, and write medical device labeling and manage labeling deliverables.
• Simultaneously manage up to two labeling updates and one small, new-product-introduction project.
• Understand and adhere to quality management system documents and product commercialization procedures.
• Conduct interviews with users and technical staff to gather data for documentation.
• Recommend formats responsive to technical and customer requirements.
• Assist in providing documentation for CAPAs and audits.
• Contribute to time and cost estimates for labeling deliverables.
• Develop illustrations in cooperation with professional illustrators.
• Oversee Engineering Change Order process for labeling.
• Coordinate translations and track status of translations.
• Complete labeling proofs and develop documentation for regulatory submissions.

Skills

Documentation

Regulatory knowledge

Cross-functional teamwork

Project management

Attention to detail

Education

University Degree

Advanced degree

Job description

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.

SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects from design to implementation while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education (typically University).

DIFFERENTIATING FACTORS Autonomy: Established and productive individual contributor. Works independently with general supervision on larger, moderately complex projects / assignments.

Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments. Contributes to the completion of project milestones . May have some involvement in cross functional assignments.

Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex . Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
Communication and Influence: Communicates primarily and frequently with internal contacts . External interactions are less complex or problem solving in nature. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decisionmaking.

Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.

Required Knowledge and Experience: Requires practical knowledge and demonstrated competence within job area typically obtained through advanced education combined with experience. Requires a University Degree and minimum of 5 years of relevant experience, or advanced degree with 2 years of experience.