Talent.com
Technical writer
Technical writerSunrise Systems Inc • New Brunswick, NJ
serp_jobs.error_messages.no_longer_accepting
Technical writer

Technical writer

Sunrise Systems Inc • New Brunswick, NJ
job_description.job_card.variable_days_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

Job Title : Technical Writer

JOB ID :  25-10480

Location : New Brunswick, NJ -  50% onsite required

Duration : 12 months(High possibility of extension for right candidate depending on performance or budget)

Work Schedule : Mon-Friday(normal business hours)

Summary

  • The Technical Writer will sit within the Cell Therapy Development and Operations (CTDO) Portfolio Strategy and Operations (PSO) Pipeline Portfolio Management Office (PMO). This individual will be responsible for delivering CMC documentation (dossier and supporting documents) to support the regulatory strategy for the Cell Therapy clinical portfolio from early stage through registrational application.
  • This role requires effective collaboration across technical functions to meet submission timelines. The position interfaces with experts in Process Development, Analytical Development, Cell Therapy Technical Ops, Quality and Regulatory Sciences across CTDO. The successful candidate will work effectively in cross-functional project teams to accomplish company goals.

Primary Responsibilities :

  • Co-authors / authors scientific content for CTD Quality sections aligned with regulatory strategy for clinical and life-cycle CMC regulatory submissions and responses to health authority questions based on high quality technical reports.
  • oPlan and facilitate submission kick-off for clinical regulatory submissions across CTD pipeline assets.
  • Manage the logistical process and detailed timeline for regulatory submissions.
  • Partner with SMEs across CTDO to identify source documents and align delivery of approved technical documents in accordance to project timelines and aligned with CTD requirements and regulatory strategy.
  • Provide input and scientific oversight for content generation for Module 2.3 and 3.
  • Must possess a thorough understanding of the source documentation requirements needed for regulatory submissions and the correlation to the authoring process.
  • Review and adjudicate comments in collaboration with technical SMEs, facilitate comment resolution, revise draft sections.
  • Ensures content clarity / consistency in messaging across dossier.
  • Facilitate and manage the data verification process.
  • Assist with dossier creation and system compliance for regulatory submissions
  • Coordinate response authoring, review and data verification to queries from HA for submissions.
  • Track upcoming submissions and ongoing submission progress
  • Maintain submission content tracker for regulatory submissions and work with doc specialist / PM / Reg CMC to update tracker.
  • Represent Tech Writing and Document management in cross-functional CMC teams as required.
  • Collaborate and coordinate with CMC matrix team leaders to ensure timely submissions.
  • Collaborate with external suppliers as needed for CTD content and review.
  • Support and implement continuous process improvement ideas and initiatives.
  • Train others on procedures, systems access and best practices as appropriate.
  • Mentor and train employees on the document management process
  • Work independently under supervision and collaborate with other teams.
  • Competencies & Experiences

  • Required Bachelor's degree in Biology or related discipline with a minimum of 2 years' experience
  • Familiarity and understanding of regulatory requirements and guidance pertaining to CMC documentation is preferred; Cell therapy CMC experience required.
  • Familiarity with eCTD structure for regulatory submissions is required; BLA experience is strongly preferred.
  • Outstanding verbal and writing communication skills, strong attention to detail, planning, organizational and negotiating skills, demonstrated ability for timely delivery.
  • Proficiency in commonly used Microsoft Office applications (Word, Excel, SharePoint, PPT) is required.
  • Experience with computer-assisted document preparation tools is preferred along with proficiency in compliance ready standards for final publication.
  • Experience in bio tech / pharma e2e product development required. Must be capable of working in a fast-paced changing team environment, prioritizing multiple tasks to meet filing deadlines.
  • Take ownership of the section – formatting, language check, connections to other sections / tables.
  • Works independently under supervision and collaborates with other team members from scientific functions, project management, document management in cell therapy.
  • Travel : Occasionally to other local NJ sites for larger team meetings.(2-3 times a year)

    The hourly rate for this position is between $40-$45 per hour.

    Compensation :

    Factors which may affect starting pay within this range may include [geography / market, skills, education, experience and other qualifications of the successful candidate].

    Benefits :

    Sunrise offers ACA-compliant medical coverage / dental insurance / vision insurance to all employees. We also offer Sick time benefits as required per State regulations.

    serp_jobs.job_alerts.create_a_job

    Technical Writer • New Brunswick, NJ

    Job_description.internal_linking.related_jobs
    Technical Writer - Product Documentation

    Technical Writer - Product Documentation

    Bloomberg • New York, NY, US
    serp_jobs.job_card.full_time
    Technical Writer - Product Documentation.Description & Requirements.Please provide writing samples with your application. We help clients get the most from Bloomberg's suite of tools and product...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Senior Technical Writer, Documentation

    Senior Technical Writer, Documentation

    Datadog • New York, NY, US
    serp_jobs.job_card.full_time
    The Technical Writing & Documentation team creates engaging and informative technical content, particularly our public product documentation : Datadog Docs. Our team isHands-on with the technolog...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Sr. Technical Writer - Hybrid

    Sr. Technical Writer - Hybrid

    Cedent Consulting • New York, NY, US
    serp_jobs.job_card.full_time
    We request candidates to provide writing samples with their application.We are seeking a skilled Technical Writer to join our IT department. The ideal candidate will be responsible for creating clea...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Technical Writer

    Technical Writer

    Integrated Resources Inc. • Somerville, NJ, US
    serp_jobs.job_card.full_time
    We deliver strategic workforce solutions that help you manage your talent and business more efficiently and effectively.Since launching in 1996, IRI has attracted, assembled and retained key employ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    (Agile1)IT - Technical Writer - Mid

    (Agile1)IT - Technical Writer - Mid

    Sunrise Systems, Inc. • Edison, NJ, US
    serp_jobs.job_card.full_time
    Agile1)IT - Technical Writer - Mid.Be among the first 25 applicants.Agile1)IT - Technical Writer - Mid.LOCAL CANDIDATES ARE STRONGLY PREFERRED OR AT LEAST CANDIDATES WITHIN THE STATE • • • The role is...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Technical Writer - Union, NJ

    Technical Writer - Union, NJ

    ADAPTATION • Union, NJ, US
    serp_jobs.job_card.full_time
    We are seeking a mid level Technical Writer that will be responsible for planning, writing, editing, and verifying high-quality technical documents. Takes ownership of assignments by working with so...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Lead Technical Writer

    Lead Technical Writer

    Cloudsmith • New York, NY, US
    serp_jobs.job_card.full_time
    Lead Technical Writer role at Cloudsmith to own and elevate the documentation experience end to end, setting standards, refining structure, and creating documentation that helps developers succeed....serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Technical Writer

    Technical Writer

    Effectual • Jersey City, NJ, US
    serp_jobs.job_card.full_time
    Effectual Technical Writers are members of the Professional Services team responsible for ensuring that customer-facing projects are delivered with exceptional customer satisfaction and technical e...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Technical writer

    Technical writer

    Innova Solutions • New Brunswick,New Jersey,United States
    serp_jobs.job_card.full_time
    serp_jobs.filters_job_card.quick_apply
    Innova Solutions has a client that is immediately hiring for a Regulatory- Technical writer.Position type : Full-time- Contract. Location : New Brunswick, NJ (50% onsite).As a Regulatory- Technical wr...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30
    Technical Writer / Regulatory Affairs (New Brunswick)

    Technical Writer / Regulatory Affairs (New Brunswick)

    TSR Consulting • New Brunswick, NJ, US
    serp_jobs.job_card.part_time
    Please only local candidates to New Brunswick NJ.MUST have Cell Therapy or Biologics experience.Staffing company with over 50 years of staffing excellence. Our client, a leading pharmaceutical compa...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Technical writer

    Technical writer

    Capgemini • Raritan, NJ, US
    serp_jobs.job_card.full_time
    E / E & Semiconductor Engineer - Technical writer.E / E & Semiconductor Engineer - Technical writer.Develop and document user and functional requirements, test cases, scripts, and validation pr...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Engineering Technical Writer

    Engineering Technical Writer

    Haydanconsultantsinc • Jersey City, NJ, US
    serp_jobs.job_card.temporary
    Services to be performed may include, but shall not be limited to, the following : .Create and Maintain Documentation.Create, revise, and format technical documentation, including SOPs, maintenance m...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Technical Writer

    Technical Writer

    Palantir Technologies • New York, NY, US
    serp_jobs.job_card.full_time
    Be among the first 25 applicants.Palantir builds the world's leading software for data-driven decisions and operations.By bringing the right data to the people who need it, our platforms empower ou...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Technical Writer

    Technical Writer

    Sibitalent Corp • Morristown, NJ, US
    serp_jobs.job_card.full_time
    Be among the first 25 applicants.Get AI-powered advice on this job and more exclusive features.Direct message the job poster from Sibitalent Corp. Note : Must have 5 years of experience in Pharma.The...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Technical Writer

    Technical Writer

    Sunrise Systems • Warren, New Jersey, United States
    serp_jobs.job_card.temporary
    serp_jobs.filters_job_card.quick_apply
    Job Title : Technical Writing Specialist.Duration : 12 Months contract on W2.Work Schedule : Mon - Fri, Business Hours.PURPOSE AND SCOPE OF POSITION : . The Technical Writing Specialist supports the succ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30
    Senior Technical Writer

    Senior Technical Writer

    CGS Federal (Contact Government Services) • New York, NY, US
    serp_jobs.job_card.full_time
    CGS Federal (Contact Government Services) is seeking an experienced Senior Technical Writer to provide consultative, analytical, and documentation support for a large Federal agency initiative.This...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Sr Technical Writer

    Sr Technical Writer

    BCforward • Morristown, NJ, US
    serp_jobs.job_card.temporary
    BCforward began as an IT business solutions and staffing firm.Founded in 1998, BCforward has grown with our customers' needs into a full service personnel solutions organization.BCforward's headqua...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Technical Writer / Regulatory Affairs

    Technical Writer / Regulatory Affairs

    TSR Consulting • New Brunswick, NJ, United States
    serp_jobs.job_card.full_time
    Please only local candidates to New Brunswick NJ.MUST have Cell Therapy or Biologics experience.Staffing company with over 50 years of staffing excellence. Our client, a leading pharmaceutical compa...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    API Technical Writer

    API Technical Writer

    Rippling • New York, NY, US
    serp_jobs.job_card.full_time
    Rippling gives businesses one place to run HR, IT, and Finance.It brings together all of the workforce systems that are normally scattered across a company, like payroll, expenses, benefits, and co...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Technical Writer

    Technical Writer

    TradeJobsWorkForce • 10111 New York, NY, US
    serp_jobs.job_card.full_time
    Research, write, edit and proofread complex technical data.Create, maintain and update manuals, procedures, specifications and other documents. Create, maintain and update installation instructions,...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted