- UpvoteDownvoteShare Job
- Suggest Revision
Author regulatory submission documentation, including SRDs, IDEs, and PMAs. Ensure that software and data products are developed and validated to standards required for FDregulated products and/or for data included as part of a drug or diagnostic regulatory submission (e.g. SRDs, IDEs, Pre-Submissions, PMA.
Full-timeExpandApply NowActive JobUpdated Yesterday - UpvoteDownvoteShare Job
- Suggest Revision
Author audit reports and coordinate supporting documentation; manage same in QMS. Bachelor’s degree in a scientific discipline with 10+ years’ experience in the pharmaceutical or biotech industry and GCP Clinical Quality Assurance.
Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
In this role, the Research Scientist will author and/or review assay development plans, project reports, procedures, and other assay-related documentation and independently execute experiments according to project plans.
$83,000 a yearFull-timeExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Author and execute design, commissioning, qualification, and validation documentation and support records to certify compliance with specifications and procedures. Strong technical documentation generation and review skills, ensuring content is technically sound and adheres to applicable site procedures.
ExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Performing annual account reviews, periodic reviews Performing GMP data quality assessments and managing deviations Managing document review and approval workflows in a global document management system Working with data archiving and electronic document management systems (in house systems are OpenLab and Veeva Quality Docs) Manage IQOQ and UAT – write and execute test scripts, author test summary reports.
ExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Plan, prepare, author, and/or review documentation and submissions (for example, IND, CTA, BLA, NDA, MAA) to Health Authorities to support clinical trials, registration, maintenance of registration, and labeling of pharmaceutical products.
Full-timeExpandApply NowActive JobUpdated 13 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Author CMC sections for filing and maintenance of INDs, CTAs, IMPDs, NDAs and MAA submissions as well as CMC source documentation for our clinical programs. Adhere to generally accepted writing standards to support CMC documentation.
Full-timeExpandApply NowActive JobUpdated 22 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Driving adherence to global regulatory guidelines relevant for the development of gene therapy products; author, review and approve, as necessary, internal documentation to ensure conformance with regulations and existing regulatory approvals.
Full-timeExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Author and develop SOP and VMP for computer system validation for manufacturing equipment. Author URS, FRS, Risk Assessments, Configuration specification, design specification and CSV test protocols and execute them in compliance with GDP guidelines and internal quality standards.
Part-timeExpandApply NowActive JobUpdated 25 days ago - UpvoteDownvoteShare Job
- Suggest Revision
As the Technical Author on the team, you will collaborate with software developers, product managers, community members, other documentation authors, information architects, quality assurance engineers and technical support engineers to develop clear documentation for complex technical topics.
Full-timeExpandApply NowActive JobUpdated 15 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Execute the SDLC Activities and develop\author key validation and System Lifecycle documents: Validation Plans and Summary Reports, Specifications (URS, FRS, CS), Testing Documentation (Plans, Test Protocols, Test Cases & Scripts), Trace Matrix etc.
Full-timeExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Author detailed product requirements documentation to ensure alignment across functions and increase velocity of throughput. This position will be directly supporting the ViewPoint Site CTMS (Clinical Trial Management System), a software platform that serves as the day to day workflow tool for clinical research coordinators, provides a digital trial protocoland includes modules to track nearly every aspect of a clinical trial, from budgeting to site management to point-of-care communication.
$155,000 a yearFull-timeExpandApply NowActive JobUpdated 20 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Author and maintain documentation as required to sustain regulatory compliance. College graduate in Biological Science, Public Health, or Regulatory Science or related field, or related experience, Masters or PhD preferred.
Full-timeRemoteExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Author and update internal and external documentation, and formally initiate and deliver business requirements and documentation. Partner with stakeholders across business units (ex: portfolio managers, quants, marketing, operations, risk, compliance) to develop analyses and documentation in a collaborative way.
ExpandApply NowActive JobUpdated 2 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Regulatory data creation to author documentation supporting filings and responses to health authorities globally. Lead and develop a drug substance team for preclinical through commercialization to support biologics program advancement.
Full-timeExpandApply NowActive JobUpdated Today
author documentation jobs in Winchester, MA
FEATURED BLOG POSTS
How to Calculate Net Income
Understanding your finances can be daunting even if you’re good with numbers. Your net income, in particular, is a key metric for determining how well you’re doing financially and whether your current way of operating is sustainable or not.
To ATS or not to ATS
As hiring is becoming more analytical and data-driven, companies have found ways to incorporate technology to help hire and recruit more efficiently. ATS, also known as an applicant tracking system, has become one of the most widely adopted technological recruiting tools to date. In fact, according to data from Capterra:
6 Best Ways to End a Cover Letter with Examples
Including a cover letter with your resume is a great way to introduce yourself to the hiring manager, tell them why you’re the ideal fit for the role, and provide context about your personal situation. A strong cover letter will give you an advantage over other applicants. But it’s important that you structure it properly and write it powerfully so that it carries an impact. This article will discuss how to end a cover letter effectively so you catch the eye of a hiring manager and increase your odds of landing an interview. Read on to learn more.
How to Write a Follow-Up Email for a Job Application?
Most times, we have to do more than submit a "sugar-coated" resume to land our dream jobs. Going the extra mile to follow up on your job application can increase your chances of employment. Additionally, it may even help you get confirmation sooner on whether you are seriously being considered for the job or not.
How to Hire Remote Workers
Remote work used to be a thing of the future. However, with social, economic, and cultural events taking place across the country, it has now evolved into something that both job searchers AND companies are benefiting from. Remote work is multifaceted and can come in handy in a variety of situations. So, to help your small business take advantage of all of remote work's benefits, here is a short guide on how to hire remote workers.
How to Address a Cover Letter With Examples
It’s easy to get caught up in focusing on your resume – how it looks, what it says, and whether it’s going to land you a job interview. Because there is a big focus on building the perfect resume, job searchers often overlook the importance of a high-quality cover letter. Your cover letter plays a huge role in your first impression. It humanizes you and provides context for your resume.
How to Call Out of Work
No matter how happy we are with our jobs, there are days when we feel overwhelmed and want to call out of work. No, don't feel guilty. It's expected because we're humans, and we can't control the uncertainties of life. But the problem lies in how to call out of work without seeming uncommitted to work, especially if you seldom get work-free days.