Technical Writer (Scientific/Life Sciences/Med Devices)

Job Title: Technical Writer

Location: Branchburg, NJ 08853 (Onsite)

Duration: 06 Months

Key Requirements for Success:

• Previous experience in pharmaceutical, medical device, or biotech industries.
• In depth knowledge of MS Word including use of tables, headers/footers, and review capabilities.
• In depth knowledge of EDMS System (Veeva Vault).
• Document management system: Quality Systems One Vault (Veeva).
• Project Management capabilities.

Job Summary:

• Seeking a Technical Writer, but not in an IT-related capacity. Strong preference for a candidate with a scientific background and excellent to extremely excellent punctuation and grammar skills.
• Role involves transitioning from a paper-based processing system to an electronic system.
• The Technical Writer III is responsible for the development, creation, and revision of controlled documentation in accordance with policies and procedures, current GMP, 21CFR820, ISO 13485 and AATB Standards. 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.
• Editing required for large volumes of documents, including batch records, SOPs, and regulatory documentation.

Education and Experience:

• University Degree BA/BS, Science, Communications, Engineering, or English (preferred)
• 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.

Essential Skills, Experience, and Competencies (includes Licenses, Credentials):

• 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.