Technical Writer

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Apex Systems
Systems, IT, Technical Writer, Recruiter, Technical Writing
Full Time

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-to-hire 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 John Lobdell, Technical Recruiter, at

Title: Technical Writer

Location: REMOTE (EST Hours)

Apex Job ID: 1169792

Rate: Negotiable based upon experience

Duration: 9+ month contract-to-hire

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

EEO Employer

Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .

Company Information

Apex Systems is a world class technology services business that incorporates industry insights and experience to deliver solutions that fulfill our clients’ digital visions. We provide a continuum of service from workforce mobilization and modern enterprise solutions to digital innovation to drive better results and bring more value to our clients. Apex transforms our customers with modern enterprise solutions tailored to the industries we serve. Apex has a presence in over 70 markets across US, Canada and Mexico. Apex is a segment of ASGN Inc. (NYSE: ASGN)

Dice Id : apexsan
Position Id : BHJOB2374_1169792
Originally Posted : 4 months ago

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