Technical Writer

Job#: 3021955

Job Description:

Apex Systems combines with parent company On Assignment to make it the 2nd largest IT staffing agency in the country.

Apex has an opportunity for a Technical Writer role based REMOTELY. This is a 9+ month contract position and the pay rate is flexible depending on experience. Here are the details:

For applicants who are interested in the Technical Writer Opportunity; please send a Word resume to

Title: Technical Writer

Location: REMOTE (EST Hours)

Apex Job ID:

Rate: Negotiable based upon experience

Duration: 9+ month contract

Position Description:

One of our biopharma clients is actively hiring a Technical Writer for their team. Candidates are expected to have 3+ years of Technical Writing experience, ideally coming from a biopharma industry background.

Tasks and Responsibilities:

• Distills technical information from multiple sources into concise and well-crafted written deliverables that are aligned with our highest standards of quality and meet both client and health authority expectations.
• Independently read and digest technical documentation pertaining to the development, manufacture, and testing of various and complex products, asking appropriate questions and conducting independent research as needed to enable the writing of summary sections for regulatory submission
• Mine through technical documents for relevant data, synthesize information, develop narratives, and construct flow diagrams, tables, and figures as needed to convey technical information
• Organize the flow of information through documents and write clear and concise technical content using well-constructed sentence and paragraph structure
• Keep abreast of pertinent health authority guidance, regulations, and trends
• With guidance from regulatory team members, clients, CRO's, utilize prior experience and knowledge of GMP and regulatory requirements to ensure that the content and level of detail is fit for purpose and appropriate for that product's development stage
• Ensure high quality deliverables are generated at appropriate stages and under agreed-upon timelines
• Review and provide feedback on the work of colleagues; contribute your technical expertise to the team and be open to learning/cross-training in other technical areas; lead and develop other team members as needed
• Reviews/approves batch records, change controls, complaints and investigations to ensure compliance with cGMP's, ICH guidelines and other regulatory requirements
• Develops/Authors SOPs
• Supports submittal of regulatory filings and responses to agency inquires
• Facilitates Interdepartmental and Intradepartmental collaboration to meet regulatory timelines
• Reviews specifications for starting materials and final product

Preferred Experiential Background:

• Must haves (at least 3):
  • GMP experience
  • 2-3 years as a technical writer
  • Experience and knowledge with documentation, quality, and tech transfers
• Nice to haves (what will get the win?):
  • Strong communication and organization
  • Experience with Veeva
  • Strong team player

Apex Systems is a world-class IT services company that serves thousands of clients across the globe. When you join Apex, you become part of a team that values innovation, collaboration, and continuous learning. We offer quality career resources, training, certifications, development opportunities, and a comprehensive benefits package. Our commitment to excellence is reflected in many awards, including ClearlyRated's Best of Staffing in Talent Satisfaction in the United States and Great Place to Work in the United Kingdom and Mexico. Apex uses a virtual recruiter as part of the application process. Click for more details.

Apex Benefits Overview: Apex offers a range of supplemental benefits, including medical, dental, vision, life, disability, and other insurance plans that offer an optional layer of financial protection. We offer an ESPP (employee stock purchase program) and a 401K program which allows you to contribute typically within 30 days of starting, with a company match after 12 months of tenure. Apex also offers a HSA (Health Savings Account on the HDHP plan), a SupportLinc Employee Assistance Program (EAP) with up to 8 free counseling sessions, a corporate discount savings program and other discounts. In terms of professional development, Apex hosts an on-demand training program, provides access to certification prep and a library of technical and leadership courses/books/seminars once you have 6+ months of tenure, and certification discounts and other perks to associations that include CompTIA and IIBA. Apex has a dedicated customer service team for our Consultants that can address questions around benefits and other resources, as well as a certified Career Coach. You can access a full list of our benefits, programs, support teams and resources within our 'Welcome Packet' as well, which an Apex team member can provide.