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Most recently, we were recognized Stevie Employer of the Year 2025, SIA Best Staffing Firm to work for 2025, Inc 5000 Best Workspaces in US (2025 & 2024) and Glassdoor's Best Places to Work (2023 & 2022)! This role demands the ability to manage concurrent projects and effectively collaborate with various engineering teams to ensure timely delivery.

HOUR

Akraya Inc.

Technical Writer-III: 26-01656

HaleyMarketing

The role drafts CMS submittal letters and integrates business engagement, stakeholder management, project management, and technical liaison activities to ensure APDs are accurate, comprehensive, and aligned with CMS requirements. This position collaborates closely with internal teams, external partners, vendors, and budget and contract offices to produce high-quality APDs that are well structured, strategically aligned, and submitted on schedule to meet federal and state requirements.

We are a $125 Million, NMSDC-certified Minority & Woman owned Workforce Solutions Company headquartered in the DC metro area with presence across US with global presence - Canada, Mexico, India, UK, Malaysia, Indonasia, Hongkong, Singapore, UAE. We are specialized in providing Workforce Solutions, SOW project delivery, Engineering Solutions, Creative Services. We currently support 100+ Fortune companies globally and across multiple industry segments. We are currently supporting several massive programs across industry segment nationally/globally (Intel, Ally, AMD, QUALCOMM, Morgan Stanley, Kraft/ Mondelez, MNP, Amdocs, Dell, SanDisk, Medtronic, Becton Dickinson, GE, Lockheed Martin, UTC, L-3 Communications, Caterpillar, BMW, Mercedes Benz, National Grid, Dominion, Energy Future Holdings, PSEG, 3M, Fidelity, Aetna, Humana, Johnson & Johnson, Pfizer, Merck etc). 
All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender, identity, national origin, disability, or protected veteran status.

Lancesoft

APD Writer

Serve as the Medical Writing representative on assigned project teams and demonstrate document leadership: communicate content requirements, coordinate and conduct interdepartmental team review of draft and final documents, schedule and lead/facilitate authoring team meetings to agree on expectations, evaluate progress on tasks, identify issues and facilitate resolutions, manage/drive the timeline, and advance document development to approval, according to Parexel or client guidelines/SOPs. Gather, review, analyze, and evaluate pertinent resources to prepare, develop, and finalize clinical documents for submission to regulatory authorities, including but not limited to: briefing documents, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical document (CTD) clinical overviews and summaries, safety update/aggregate reports, and integrated summaries of safety and efficacy.

The expertise and passion for excellence shared by our people around the world unites us in our mission and drives our success. As a premier service provider to the global biopharmaceutical industry, we give you the opportunity to work with industry-leading clients in an exciting, collaborative environment where career choices and development paths are abundant, and projects are challenging. In fact, PAREXEL works with the top 50 global pharmaceutical companies, the top global biotech companies, and hundreds of small and emerging companies. With over 30 years of experience, we have supported the development of some of the most important treatments of our time, including nearly all of the 50 top selling drugs currently on the market. We offer our employees the ability to make a difference globally, while we support them locally in environments full of challenge, collaboration, flexibility and industry-leading growth potential. Discover a career at PAREXEL, where exciting challenges and opportunities await you.

Parexel International Corp

Senior Medical Writer - FSP

In this exciting role, you'll be at the heart of our business development efforts, working with senior leaders and cross-functional teams to create compelling, client-winning proposals and contracts. Team Player: You're confident collaborating across all levels, from frontline staff to senior executives, and you thrive in a supportive, team-oriented environment.

Strategic Proposal Writer

While we have been improving lives of HIV patients for 30 years, this is an especially exciting time to be at ViiV Healthcare, as we evaluate novel approaches to treatment and prevention that could further reduce the impact of HIV on individuals and communities. Please note that if you are a US Licensed Healthcare Professional or Healthcare Professional as defined by the laws of the state issuing your license, GSK may be required to capture and report expenses GSK incurs, on your behalf, in the event you are afforded an interview for employment.

GSK plc

Principal Medical Writer

Write and edit clinical development documents, including but not limited to, clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Module 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5 documents, presentation materials and publications to medical journals. Our mission is to deliver high-quality service and technology solutions – rooted in strong science and decades of regulatory experience – that will assist our clients in developing and marketing life-changing therapies to positively improve lives worldwide.

Staff Writer Jobs in Morrisville, NC

Technical Writer-III: 26-01656 Akraya Inc.

APD Writer Lancesoft

Senior Medical Writer - FSP Parexel International Corp

Strategic Proposal Writer Parexel International Corp

Principal Medical Writer GSK plc

Senior Medical Writer (Remote) MMS

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