- UpvoteDownvoteShare Job
- Suggest Revision
Serve as a subject matter expert in areas of healthcare regulatory law, including rules and regulations of the FDA, OIG and CMS and antikickback legislative obligations, Stark Law, qui-tam risks, and product liability statutes and regulations.
ExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
- Suggest Revision
The ideal applicant is a subject matter expert in radiation device effects and implications on the resulting system design. Distinguished Radiation Effects Subject Matter Expert.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Serve as the subject matter expert on Veeva Vault and related clinical trial management systems (CTMS), electronic trial master file (eTMF), and regulatory document management systems.
ExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Fundamental understanding of radiation transport tools such as CEPXS, MCNP and/or GEANT. Ability to model multi-physics devices and systems using TCAD, SPICE, Comsol or similar tools. This includes an understanding of radiation physics and relevant semiconductor device modeling (e.g. TCAD.
Full-timeExpandApply NowActive JobUpdated 5 months ago - UpvoteDownvoteShare Job
- Suggest Revision
Represent Regulatory Writing on cross-functional teams, working in close partnership with regulatory affairs, clinical and nonclinical subject matter experts (SMEs) from pharmacology, drug metabolism and pharmacokinetics (DMPK), toxicology, and other internal stakeholders and external collaborators/CROs.
Full-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Contribute to the planning and management of cross-functional regulatory submission components (clinical, nonclinical, CMC), including meeting requests, briefing documents, IND/CTA/NDA/MAA documents for products in the company portfolio.
Full-timeExpandApply NowActive JobUpdated 11 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Serve as the subject matter expert on cross-functional teams to lead projects, direct GLP bioanalytical validations and sample analysis across all nonclinical and clinical pharmacology development.
ExpandApply NowActive JobUpdated 3 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Bachelor's degree (BA/BS) in a scientific discipline required and advanced degree preferred with a minimum of 10 years' experience in drug development/regulatory affairs and a minimum 8 years in CMC regulatory affairs.
Full-timeExpandApply NowActive JobUpdated 7 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Within Global Regulatory Affairs, our Chemistry, Manufacturing and Controls (CMC) organization provides regulatory leadership to CMC development teams and the Pharma Supply Chain organization to enable approval of new medicines and uninterrupted supply of our medicines to patients.
Full-timeExpandApply NowActive JobUpdated 12 days ago - UpvoteDownvoteShare Job
- Suggest Revision
The Retirement Plan Consultant (RPC) acts as a subject matter expert and works in partnership with a Senior Retirement Plan Strategist (external wholesaler) to achieve an annual sales goal.
ExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Provides oversight of case processing activities for the Xenon clinical development program and serves as safety data management subject matter expert (SME) on regulations and best practices for conventions and handling of safety data in Xenon’s global safety database (GSDB.
$210,000 - $239,500 a yearExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
This individual will report directly to the Sr. Director, Chief Compliance Officer and will support the CCO as a subject matter expert with any duties as assigned, being agile and flexible, as these may change from time to time.
$108,000 - $143,000Full-timeExpandApply NowActive JobUpdated Today - UpvoteDownvoteShare Job
- Suggest Revision
Experience in providing regulatory CMC strategy for submission of clinical trial application (IMPD/IND) and marketing authorization application (NDA/MAA) for small molecule development compounds, including chemical drug, peptide and oligonucleotide.
ExpandApply NowActive JobUpdated 14 days ago - UpvoteDownvoteShare Job
- Suggest Revision
Establish or strengthen professional relationships with the medical and scientific community and compliantly exchange scientific knowledge with thought leaders and HCPs, including 1:1 interactions, congress engagements, and advisory boardsLead or support Late-Stage (phase 4) Clinical Development and data generation activitiesBe a subject matter expert, sharing knowledge and providing informed recommendations to other functions as needed.
Full-timeExpandApply NowActive JobUpdated 4 days ago - UpvoteDownvoteShare Job
- Suggest Revision
You are able to provide senior level subject matter expertise on land use and land use change related topics, including but not limited to: Agricultural management practices, farm-level assessments, annual and perennial cropping systems, regenerative agriculture, soil carbon accounting, carbon sequestration, biogenic carbon emissions, land use change, deforestation, watershed management, water impact assessment, and forestry management.
Full-timeExpandApply NowActive JobUpdated 3 days ago
regulatory affairs subject matter expert jobs Company: Allways Health Partners in Boston, MA
FEATURED BLOG POSTS
What is Career Cushioning?
Is your organization prepared for “career cushioning”?
Growing Discontent: Employees Wouldn't Wish Their Jobs on Their Worst Enemy
The start of a new year, and most people are already busy setting personal and professional goals. What’s on the top of the list for a growing number of working people is making an exit from the job they currently have. Why?
How to Gracefully Quit a Job You Just Started
You’ve just started learning the ropes at your new job, and you've gotten to know your colleagues. But you’re already thinking about quitting. Maybe you were deciding between to job offers and realized that you’ve made the wrong choice. Or, a change in your personal circumstances means that you have to quit.
How to Professionally Reschedule a Job Interview Without Destroying Your Chances
You’ve practiced answering common interview questions and refined your “greatest weakness.’ Nothing can stop you until BAM! The flu hits your household. Or you ran over a nail and popped a tire en route to the interview. When you need to pivot, there’s a good, better, and best way to reschedule a job interview. Here’s how to do it professionally, so you can nail the gig when the timing is right.
What is a W-9 and How to Fill One Out
When you began working for yourself, you probably didn’t account for the tax reporting work that will fall on your shoulders each year. If you’re a freelancer, independent contractor, or business owner, filing your taxes is not as simple as uploading your W-2 form into some online tax preparation software. Most self-employed people need to complete a W-9 as a step for accurately reporting their earnings to the IRS. Below, you can learn how to fill out a W-9 and when to submit it.
Tightening the HR budget in 2023
With the state of the economy still uncertain, 2023 is expected to be approached with much anticipation. Human Resource leaders have many concerns, including how they will manage to accomplish their goals with budget belts already getting snug. Let’s look at some of the factors that the new year is projected to bring for HR and how to prioritize budgets to reach human capital objectives.
A Comprehensive Guide to Becoming a Better Conversationalist
Have you ever stood awkwardly next to someone at a party because you didn’t know what to say to them? How about at a networking event or on a first date? You're not alone if you’ve ever experienced this uncomfortable silence. Many people struggle to master the art of being a great conversationalist.