Technical Writer (Change Control/Management) - Planet Interactive : Job Details

Planet Interactive is seeking a Technical Writer (Change Control/Management)

to join one of our well-known global pharmaceutical clients.

Duration: 6 months with possible extension- based on performance and business needs.

Location/Address: Sommerville, NJ

Remote/Hybrid: Onsite with some remote days.

Pay Rate: Up to $63.25/hr (W2 and benefit options)

The Technical Writer is responsible for the development, creation, and revision of controlled documentation in accordance with the client's policies and procedures, current standards.

Technical Writer Responsibilities:

• Establishes partnerships and works with Change Control, Quality Engineer team members, and other cross functional managers/supervisors and development engineers/teams to ensure that controlled documents being revised contain the correct information per process/product specifications.

• Technical Writer Qualifications:
• Previous experience in pharmaceutical, medical device, or biotech industries.
• 3-5 years' experience in Technical Writing in a GMP or medical device manufacturing environment.
• In-depth knowledge of MS Word including use of tables, headers/footers, and review capabilities.
• In depth knowledge of EDMS Systems (e.g. Veeva Vault).
• Project Management capabilities.
• In depth knowledge of document authoring tools, including MS Office Suite.
• Demonstrated ability in proofreading and editing.
• Ability to multi-task and adjust to shifting priorities.
• Strong interpersonal skills including the ability to effectively work and actively communicate with people and cross-functional teams.
• Excellent oral and written communication skills as well as strong organizational skills.
• Strong analytical skills, with an eagerness to work hard and achieve exemplary results.
• Expert grammatical competency and writing skills.
• Basic knowledge of FDA, GXP, 21CFR820, ISO 13485 and AATB requirements and industry best practices.
• Previous experience in pharmaceutical, medical device, or biotech industries.
• Previous experience in pharmaceutical, medical device, or biotech industries.
• In depth knowledge of EDMS System (Veeva Vault) a plus
• Project Management capabilities.
• University Degree BA/BS, Science, Communications, Engineering, or English (preferred).