Current jobs related to Regulatory Content Specialist - Reston, Virginia - BioPhase

  • Regulatory Affairs Specialist

    2 weeks ago

    Reston, Virginia, United States Cypress HCM Full time

    Job Title: Senior Regulatory Affairs SpecialistLocation: Cypress HCMExperience: Must have experience composing submissions for IVD devicesPosition Overview:The Senior Regulatory Affairs Specialist will coordinate the collection of technical information and prepare regulatory submissions for in vitro diagnostic (IVD) and medical device licenses for various...

  • Regulatory Affairs Specialist

    1 week ago

    Reston, Virginia, United States Cypress HCM Full time

    Job Title: Senior Regulatory Affairs SpecialistLocation: San Diego, CAExperience: Must have experience composing submissions for IVD devicesPosition Overview:The Sr. Regulatory Affairs Specialist will coordinate the collection of technical information and prepare regulatory submissions for in vitro diagnostic (IVD) and medical device licenses for various...

  • Content Specialist

    1 week ago

    Reston, Virginia, United States TalentBurst, an Inc 5000 company Full time

    Job Title: Content SpecialistLocation: RemoteDuration: 06+ MonthsJob DescriptionTalentBurst, an Inc 5000 company, is seeking a skilled Content Specialist to support the creation of high-quality documentation. The ideal candidate will have expertise with Microsoft Office and be fluent in creating engaging content.Day to Day:Collaborate with engineering staff...

  • Digital Content Specialist

    3 weeks ago

    Reston, Virginia, United States Manomet Conservation Sciences Full time

    Job Title: Digital Content SpecialistManomet Conservation Sciences is seeking a highly skilled Digital Content Specialist to join our team. As a key member of our marketing and communications department, you will play a crucial role in helping us achieve our mission by developing and distributing timely, relevant content for our audiences.About the RoleThe...

  • Marketing Content Specialist

    1 week ago

    Reston, Virginia, United States Ultimate Staffing Full time

    Marketing Content SpecialistAbout the Role:We are seeking a skilled Marketing Content Specialist to create engaging content that drives business results. This role involves researching, writing, and editing materials for print and web-based communications.Key Responsibilities:Developing and implementing content marketing strategies to reach target...

  • Technical Content Specialist

    2 weeks ago

    Reston, Virginia, United States FastTek Global Full time

    FastTek GlobalJob Title: Technical Content SpecialistAbout the Role:We are seeking a skilled Technical Content Specialist to join our team. As a Technical Content Specialist, you will be responsible for creating high-quality technical documentation that meets the needs of our customers.Key Responsibilities:• Develop and maintain technical documentation for...

  • Ecommerce Content Strategist

    2 days ago

    Reston, Virginia, United States Beurer North America Full time

    Ecommerce Content and Strategy SpecialistBeurer North America is seeking a dynamic and results-driven Ecommerce Content and Strategy Specialist to join our mid-sized team in Hollywood, Florida. As an Ecommerce Content and Strategy Specialist, you will be responsible for developing and implementing content strategies that drive online sales growth and improve...

  • Digital Content Specialist

    1 week ago

    Reston, Virginia, United States Manomet Conservation Sciences Full time

    Job SummaryThe Digital Content Specialist plays a crucial role in supporting the organization's marketing and communications strategies. This position will report to the Senior Director, Marketing and Communications to help execute Manomet's plans for growth by developing and distributing timely, relevant content for various audiences. The ideal candidate...

  • Content Creation Specialist

    2 weeks ago

    Reston, Virginia, United States Daon Inc Full time

    Job Summary: Daon Inc is seeking a highly skilled Content Creation Specialist to join our team. The ideal candidate will have a strong background in marketing content writing and be able to create engaging content for our international audience.Key Responsibilities:* Develop high-quality written materials for marketing campaigns* Collaborate with subject...

  • Technical Content Specialist

    1 week ago

    Reston, Virginia, United States SEB Professional North America Full time

    About the RoleWe are seeking a skilled Technical Content Specialist to join our team at SEB Professional North America. As a Technical Content Specialist, you will be responsible for creating high-quality technical documentation that empowers users and enhances their experience with our products.Key Responsibilities:Develop, write, and maintain clear and...

  • Regulatory Affairs Specialist

    3 weeks ago

    Reston, Virginia, United States BioTalent Full time

    Job Title: Senior Regulatory SpecialistLocation: Bay AreaCompany: BioTalent, a leading medical technology company, is seeking a highly skilled Senior Regulatory Specialist to join its team.Responsibilities:Develop and execute regulatory strategies for Class III medical devices, ensuring compliance with FDA regulations.Collaborate with cross-functional teams...

  • Digital Content Specialist

    2 weeks ago

    Reston, Virginia, United States TechnoSmarts, Inc. Full time

    We are seeking a highly motivated and creative Digital Content Specialist to join our team at TechnoSmarts, Inc. as a TikTok Content Creator. This is a 6-month contract position with potential for extension.The ideal candidate will have a passion for producing engaging video and static content for social media platforms like TikTok and Instagram. They will...

  • Technical Content Specialist

    1 month ago

    Reston, Virginia, United States Zillion Technologies, Inc. Full time

    Job Summary:Zillion Technologies, Inc. is seeking a highly skilled Technical Content Specialist to join our team. As a key member of our documentation team, you will be responsible for creating and editing a wide range of technical content, including training materials, user guides, and technical documentation.Key Responsibilities:Develop and maintain...

  • Regulatory Affairs Specialist

    2 weeks ago

    Reston, Virginia, United States Meet Full time

    Regulatory Affairs SpecialistLocation: Our innovative client is seeking a Regulatory Affairs Specialist to support regulatory submissions and ensure global compliance with regulatory standards. This role is crucial in managing and preparing documentation for product lifecycle management and licensing activities.Key Responsibilities:Prepare and coordinate...

  • Regulatory Affairs Specialist

    1 month ago

    Reston, Virginia, United States BioTalent Full time

    Job Title: Senior/Principal Regulatory SpecialistLocation: Bay AreaCompany: BioTalent, a leading medical technology company, is seeking a highly skilled Senior/Principal Regulatory Specialist to join its team.Responsibilities:Develop and execute regulatory strategies for Class III medical devices, ensuring compliance with FDA regulations.Collaborate with...

  • Technical Content Specialist

    3 weeks ago

    Reston, Virginia, United States Insight Global Full time

    Job Title: Technical Content SpecialistJob Summary:Zoox is developing autonomous mobility from the ground up, including creating a unique vehicle tailored to autonomous driving. The Base Operations team at Zoox supports all fleet-level maintenance, repair, and upgrade operations. This includes the back-end engineering team that delivers various aspects of...

  • Civil Engineer Content Specialist

    2 weeks ago

    Reston, Virginia, United States American Society of Civil Engineers (ASCE) Full time

    Job OpportunityWe are seeking a highly skilled Content Specialist to join our team at the American Society of Civil Engineers (ASCE). As a key member of our content team, you will be responsible for planning and creating engaging content across various platforms that support and grow our organization's content strategy.Key Responsibilities:Develop and...

  • Marketing Content Specialist

    1 month ago

    Reston, Virginia, United States AGG Legal Staffing Full time

    Job Title: Marketing SpecialistAbout the Role:The Marketing Specialist will serve as a key liaison for marketing activities that support the day-to-day operations of the lawyer biography function within Marketing Communications. This role will work closely with the Marketing Manager to manage process, quality control, and training initiatives related to...

  • Regulatory Affairs Specialist

    1 month ago

    Reston, Virginia, United States NeuroVasc Technologies, Inc. Full time

    Senior Regulatory Affairs SpecialistWe are NeuroVasc Technologies, a company that delivers excellence through innovation with integrity.This role is on-site and reports directly to the CEO. The Senior Regulatory Specialist is responsible for planning, directing, and coordinating global product registrations and leading regulatory submissions planning and...

  • Regulatory Affairs Specialist

    1 month ago

    Reston, Virginia, United States NeuroVasc Technologies, Inc. Full time

    Senior Regulatory Affairs SpecialistWe are NeuroVasc Technologies, a company that delivers excellence through innovation with integrity.This role is on-site and reports directly to the CEO. The Senior Regulatory Specialist is responsible for planning, directing, and coordinating global product registrations and leading regulatory submissions planning and...

Regulatory Content Specialist

2 months ago

Reston, Virginia, United States BioPhase Full time

BioPhase Solutions is a leading recruitment agency specializing in placing top talent in Southern California's scientific community. We are currently seeking a highly skilled Regulatory Content Specialist to join a prominent biotechnology company in the Greater Los Angeles area.

Compensation: $100-150/hour, depending on experience

Contract Type: 1099 Contract

Contract Duration: 2+ months with a high chance of extension

About the Role:

The Regulatory Content Specialist will be responsible for creating high-quality regulatory documents, including clinical study reports, clinical summaries and overviews, study protocols, Investigator's brochures, and informed consent forms. This role may also involve planning, managing, and preparing internal and external communications of key scientific and clinical data, including abstracts, poster and oral presentations, manuscripts, congress materials, and educational/training materials.

Key Responsibilities:

  • Develop, edit, and finalize CSRs, clinical summaries and overviews, eCTD summaries, study protocols, IBs, ICFs, and other clinical study-related regulatory documents.
  • Write, edit, and finalize clinical and non-clinical publications, congress materials, educational/training materials, and other external-facing documents.
  • Communicate effectively with diverse audiences, including scientists, physicians, payers, regulators, and patients.
  • Collaborate with other functional groups (e.g., Regulatory Operations, Biometrics, Clinical Operations) to gather source data and prepare regulatory documents.
  • Lead document review meetings and discussions.
  • Provide direction and solutions to cross-functional teams on document content expectations.
  • Perform quality control of clinical and nonclinical documents.
  • Ensure documents are suitable for eCTD regulatory submissions by conducting appropriate formatting and hyperlinking per writing guidelines.

Requirements:

  • Bachelor's or Master's degree in a related life-science field.
  • Experience in NDA submissions and writing CSRs, IBs, clinical study protocols, and other documents for regulatory submissions.
  • Strong scientific background in oncology, immunotherapy, or a related field.
  • Proficient knowledge of AMA writing guidelines.
  • Excellent verbal and written communication skills in English.
  • Knowledge of FDA, EMA, and ICH guidelines.
  • Deep understanding of the drug development process and prior experience in the biopharmaceutical industry.