We have other current jobs related to this field that you can find below

  • Senior Development Writer

    4 weeks ago

    Remote, Oregon, United States Bread & Roses Community Fund Full time

    About the Role Bread & Roses Community Fund seeks a highly experienced writer/editor to join its expanding development and communications team. The Senior Development Writer will create persuasive cultivation, solicitation, and stewardship materials for a wide range of audiences, including individual donors and institutional funders. This individual will...

  • Senior UX Technical Writer

    2 months ago

    Remote, Oregon, United States Huntress Full time

    Reports to: Head of UX DesignLocation: Remote USCompensation Range: $130,000 to $150,000 base plus bonus and equity What We Do:Founded in 2015 as a fully remote company by former NSA cyber operators, Huntress was built on a simple premise: to force hackers to earn every inch of their access. Today's cyber-attacks aren't limited to large organizations with...

  • Senior Technical Writer

    2 weeks ago

    Remote, Oregon, United States Crunchyroll Full time

    About CrunchyrollWE HELP EVERYONE BELONG. IT'S OUR PURPOSE.Founded by fans, Crunchyroll delivers the art and culture of anime to a passionate community. We super-serve over 100 million anime and manga fans across 200+ countries and territories, and help them connect with the stories and characters they crave. Whether that experience is online or in-person,...

  • Technical Writer Intern

    2 months ago

    Remote, Oregon, United States Versapay Full time

    About Versapay For growing businesses that need to accomplish more with less, Versapay's Accounts Receivable Efficiency Suite simplifies the invoice-to-cash process by automating invoicing, facilitating B2B payments, and streamlining cash application with AI. Versapay integrates natively with top ERPs, while allowing businesses to collect with a self-serve...

  • RFP Content Management Writer

    3 months ago

    Remote, Oregon, United States The Cigna Group Full time

    The job profile for this position is Proposal Support Senior Analyst, which is a Band 3 Senior Contributor Career Track Role.Excited to grow your career?We value our talented employees, and whenever possible strive to help one of our associates grow professionally before recruiting new talent to our open positions. If you think the open position you see is...

  • Technical Writer

    2 months ago

    Remote, Oregon, United States Bullhorn Full time

    For the past 25 years, Bullhorn has dedicated itself to building industry-leading, cloud-based software for the staffing and recruitment industry. Led by the original co-founder, partnered with venture capital, and powered by seasoned leaders across a global workforce with an eye toward innovation, Bullhorn has had year over year growth, making it the market...

  • Writer & Editor, Branded Content

    3 weeks ago

    Remote, Oregon, United States Adweek Full time

    ABOUT USADWEEK is the leading source of news and insight serving the marketing and advertising industry. First published in 1979, ADWEEK's award-winning coverage reaches an engaged audience of more than 6 million professionals across platforms including print, digital, events, podcasts, newsletters, and social media. As a touchstone of the advertising and...

  • News & Entertainment — Reporters/Writers/Editors

    1 month ago

    Remote, Oregon, United States Mystify Entertainment Network, Inc. Full time

    We deliver the best in celebrity news, entertainment and pop culture with wit, irreverence, and authority. Over the past 20 years, our leading global brands have evolved into an exclusives powerhouse.We are seeking suitability qualified candidates to help expand our digital coverage.The right candidates will be either:An enterprising journalist who can find,...

  • Sr. API Technical Writer

    3 weeks ago

    Remote, Oregon, United States Smartsheet Full time

    Smartsheet is a tech company with a human story to tell. We're here to empower teams to manage projects, automate workflows, and rapidly build new secure solutions, using simple no-code tools. We're revolutionaries – so for us changing the way the world works is all in a day's work.Smartsheet is seeking an experienced Senior API Technical Writer to plan,...

  • Scientific Technical Writer III

    3 weeks ago

    Remote, Oregon, United States Freenome Full time

    Why join Freenome?Freenome is a high-growth biotech company developing tests to detect cancer using a standard blood draw. To do this, Freenome uses a multiomics platform that combines tumor and non-tumor signals with machine learning to find cancer in its earliest, most-treatable stages. Cancer is relentless. This is why Freenome is building the clinical,...

  • Content Writer, Software Engineering

    4 weeks ago

    Remote, Oregon, United States Flatiron School Full time

    At Flatiron School, we are on a mission to transform lives through education, guiding career changers as they embark on an exciting journey toward dynamic careers in the tech industry. Our diverse student body is united in their aspiration to excel in cutting-edge fields such as Software Engineering, Data Science, Product Design, and Cybersecurity. We are...

  • Senior Content Editor

    3 days ago

    Remote, Oregon, United States Bobit Full time

    We are looking for a meticulous, organized, and proficient writer and editor to enhance our content division.The ideal candidate for the Senior Content Editor position should be a talented and adaptable content creator/reporter/editor who can seamlessly navigate various multimedia and social media platforms while significantly contributing to our diverse...

  • Oncology Medical Writer

    4 weeks ago

    Remote, Oregon, United States Pfizer Full time

    Why Patients Need YouPfizer colleagues play a key role in connecting evidenced based, medical decision support with colleagues and stakeholders to enable better health and treatment outcomes. Whether you are creating framework necessary to ensure our evidence is scientifically sound, providing unbiased, medically necessary expertise or investigating how to...

  • Senior Major Gifts Manager

    2 months ago

    Remote, Oregon, United States Indivisible Project Full time

    Reporting to the Director of Major Gifts, the Senior Major Gifts Manager is responsible for creating and implementing strategies to retain existing major gift donors, upgrade their giving, and bringing in new prospects to Indivisible.To be successful in this role, the Senior Major Gifts Manager is expected to be proactive, a strong writer, communicate...

  • Senior Accountant

    3 weeks ago

    Remote, Oregon, United States Medical Guardian Full time

    DescriptionSummaryWe are looking for a detail-oriented senior accountant to perform and coordinate accounting duties within our organization. The senior accountant's responsibilities include preparing financial reports, performing account reconciliations, maintaining the general ledger, assisting with audit preparations, and performing other accounting...

  • Senior Copywriter

    1 month ago

    Remote, Oregon, United States Technology & Services Industry Association (TSIA) Full time

    DescriptionThe Senior Copywriter at TSIA plays a pivotal role in shaping and delivering the organization's messaging, branding, and communication efforts. This role involves crafting compelling and effective written content that resonates with target audiences, drives engagement, and supports TSIA's goals. The Senior Copywriter collaborates closely with...

  • Manager, Medical Writing

    4 weeks ago

    Remote, Oregon, United States Pfizer Full time

    Job SummaryThe Medical Writer (Manager) creates documents pertaining to clinical studies and regulatory interactions, including (but not limited to) protocols, clinical study reports, briefing documents, clinical summaries for marketing applications, and responses to queries from regulatory authorities.Understands the principles of scientific writing,...

  • Senior Product Strategist

    4 days ago

    Remote, Oregon, United States Huntington National Bank Full time

    Product Group Manager - Job OverviewRole Summary:Formulates and executes the strategic vision for the payments Developer portal and API Sandbox. Conducts market analysis and gathers customer insights to shape the product development roadmap. Oversees the creation and management of developer resources, including API documentation, instructional guides, and...

  • Senior Content Marketing Manager

    2 months ago

    Remote, Oregon, United States Apollo Full time

    is the leading go-to-market solution for revenue teams, trusted by over 500,000 companies and millions of users globally, from rapidly growing startups to some of the world's largest enterprises. provides sales and marketing teams with easy access to verified contact data for over 270 million B2B contacts, along with tools to engage and convert these...

  • Medical/Senior Medical Director

    2 months ago

    Remote, Oregon, United States Thermo Fisher Scientific Full time

    Work ScheduleOtherEnvironmental ConditionsOfficeJob DescriptionOverview:Provides medical oversight of clinical trials to ensure company SOPs, client directives, good clinical practice, and regulatory requirements are followed. Attends and presents at investigator and sponsor meetings, provides medical consultation to clients, investigators and project team...

Senior Medical Writer-FSP

3 months ago

Remote, Oregon, United States Parexel Full time

Parexel FSP is looking for a Senior Medical Writer- This position is remote and can be located anywhere in the United States or Canada

Extensive Phase 1 and PK (pharmacokinetic) experience required. Protocol and CSRs (full and synoptic) writing in a range of therapeutic areas also required.

Job Purpose:

The Senior Medical Writer is responsible for the development of medical writing deliverables that support the clinical regulatory writing portfolio and works with guidance and oversight to achieve goals.

Key Accountabilities:

Leadership


• Leads cross-functional teams to draft agreed-upon scientific/medical content

that addresses data interpretation, product claims, and internal/external questions


• Coordinates and delivers document kick-off meetings with contributors or

representatives from cross-functional groups


• Coordinates activities for document review, consensus meeting, quality

control, and document finalization under aggressive timelines


• Ensures communication between members remains open and information is

disseminated appropriately


• Possible participation in the orientation and coaching of junior team

members

Regulatory Document Authoring


• Develops, coordinates, and oversees work plans for both individual and

multiple-document delivery, with all the needed tasks and subtasks, timelines, and assigned roles and responsibilities that enable the team to work efficiently and effectively to deliver all milestone tasks and documents within specified timelines


• Develops and maintains timelines in project plans, using project tracking

application following standard templates


• With minimal guidance from senior members of writing staff, prepares clinical

study reports (CSRs), protocols, investigator brochures (IBs), submission

data summaries, and other regulatory documents on investigational drugs in various stages of clinical development


• Manages messaging for consistency with historical information and in

alignment with agreed-upon strategy


• Applies lean authoring principles as part of document development and,

when applicable, structured content management (SCM) text libraries as part

of authoring process


• Ensures adherence to standard content, lean authoring, and messaging

across team members


• Works as an active member of cross-functional teams representing Medical

Writing


• Conducts appropriate literature searches, as needed

Compliance with Parexel Standards


• Complies with required training curriculum


• Completes timesheets accurately as required


• Submits expense reports as required


• Updates CV as required


• Maintains a working knowledge of and complies with Parexel processes,

ICH-GCPs and other applicable requirements

Skills:


• Focused writing and editing following defined processes and templates


• Expert level authoring in MS Word, understanding of MS Word functionality, and works with Word

add-ins that facilitate the management of fonts, styles, references, etc


• Follows directions, templates, and structured processes for delivering documents for review and finalization


• Participates in Medical Writing department initiatives, as appropriate.


• Researches regulatory requirements to remain current in the regulatory landscape


• Shares lessons learned and best practices


• Ability to work independently


• Ability to move across therapeutic areas to support business continuity and resource needs


• Ability to manage the tasks, roles, responsibilities, and timing of the authoring team, internal/external contributors, and reviewers to facilitate document completion


• Customer focused with communication skills commensurate with a professional working environment as well as effective time management, organizational, and interpersonal skills


• Fluent in reading and writing American English

Knowledge and Experience:


• Minimum 5 years in writing regulatory documents supporting global filings


• Oncology and/or Infectious Disease/Vaccines experience


• Strong knowledge of regulatory guidelines/requirements and other regional guidelines such as those from the EU and US


• Regulatory filing experience with a focus in authoring a broad set of different clinical document types that support regulatory filings such as protocols, amendments, CSRs, and common technical document summary documents with a preference for experience with Module 2.7, 5.2, CSRs, protocols, amendments, and IBs


• Understanding of clinical development process from program planning to submission, including clinical trial design as well as medical practices regarding procedures, medications, and treatment for different disease states


• Ability to facilitate review meetings, address feedback, and negotiate solutions/agreements


• Ability to interpret data and apply scientific knowledge to support regulatory document writing (i.e., IBs, protocols, amendments, CSRs, clinical summaries) as well as build clinical or regulatory arguments in the absence of direct data using logic, analogy and therapeutic area science


• Ability to develop and use story boards to drive statistical output planning, link data results to key messages, and develop templates as starting points for authoring


• Experience working on cross-functional teams with the ability to drive document content to support lean authoring


• Experience working in collaborative authoring tools and review tools, project tracking applications and document management systems; managing workflows eApproval/esignatures; and familiar with SCM and ability to author in an SCM environment using text libraries


• Flexibility in adapting to new tools and technology with capability of providing insight, alternatives, and suggestions based on previous experiences


• Capable of training writers/authors on the use of templates, guidelines, and tools

Education:

Bachelor's degree or equivalent (Life Science preferred)
#LI-REMOTE