FSP Document Review Specialist
3 weeks ago
Standard (Mon-Fri)
Environmental Conditions
Office
Job Description
At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies. With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.
Discover Impactful Work:
We are looking for a Document Review Specialist to join our FSP Medical Writing team. This role would be dedicated to one client and fully remote. As a Document Review Specialist, you will review documents to ensure quality of a standard that meets or exceeds client's expectations. Documents include: regulatory submissions, integrated clinical study reports, serious adverse event narratives, study protocols and publications. You will be ensuring integrity of data in tables against source documents, instructing others outside of the quality review group on the review process.
A Day in the Life:
• Reviews highly technical documents of all types to ensure a quality standard that meets or exceeds client expectations.
• Ensures scientific logic and clarity of the document by verifying data in tables against source documents, checking for consistency according to current regulatory standards and guidelines.
• Edits for accuracy, consistency, and grammatical correctness
• Revises scientific language for usage, flow, clarity, and audience appropriateness.
• Proactively queries authors to ensure compatibility with unique preferences and scientifically sound judgment.
• Maintains, communicates, and applies knowledge of current guidelines, templates and industry standards.
Keys to Success:
- Bachelor's degree or equivalent and relevant formal academic / vocational qualification
- Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 2+ years').
- Capable of concentrating on the details of a document without losing sight of the overall objectives and intent of the document's message
- Good knowledge of the methods, techniques, and procedures of medical writing tasks
- Strong analytical ability
- Good working knowledge of medical terminology, statistical concepts, GCP, guidelines (e.g., ICH) and requirement of the FDA and other international regulatory agencies
- Detail oriented, thorough and methodical
- Proficient grammatical and communication skills, both oral and written
- Good organizational and planning skills
- Proven ability to work effectively in a team environment
- Advanced computer literacy and expertise
- Good understanding of document management systems
- Capable of working well under pressure and remaining motivated
- Capable of working both independently and collaboratively with a team in a cross-cultural, geographically dispersed environment
Our Mission is to enable our customers to make the world healthier, cleaner and safer. As one team of 100,000+ colleagues, we share a common set of values - Integrity, Intensity, Innovation and Involvement - working together to accelerate research, solve complex scientific challenges, drive technological innovation and support patients in need. #StartYourStory with PPD, part of Thermo Fisher Scientific, where diverse experiences, backgrounds and perspectives are valued.
-
Senior Medical Writer-FSP
2 months ago
Remote, Oregon, United States Parexel Full timeParexel FSP is looking for a Senior Medical Writer- This position is remote and can be located anywhere in the United States or CanadaExtensive 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...
-
RN - Clinical Documentation Specialist
2 months ago
Remote, Oregon, United States SSM Health Full timeIt's more than a career, it's a callingMO-REMOTEWorker Type:RegularJob Highlights:At SSM Health, we believe in providing our employees with a fulfilling career. We strive to create an environment where individuals can grow both personally and professionally. Our company values diversity, innovation, and collaboration, and we are committed to making a...
-
Documentation Specialist
3 weeks ago
Remote, Oregon, United States Better Health Full timeWe are seeking a highly motivated individual to be a part of our Documentation and Insurance Verification team. This role will be responsible to collect provide day-to-day guidance to this small team (5 staff members) while also becoming an expert in performing insurance verifications and chasing documentation requirements for Durable Medical Equipment (DME)...
-
Remote, Oregon, United States SSM Health Full timeIt's more than a career, it's a calling.MO-REMOTEWorker Type:RegularJob Summary:Reviews medical record for risk of mortality (ROM) and intensity of services (IOM). Collaborates with physician regarding accurate documentation reflecting the care patient is receiving.Job Responsibilities and Requirements:PRIMARY RESPONSIBILITIESReviews electronic medical...
-
Legal Documentation Specialist II
3 weeks ago
Remote, Oregon, United States Pathward Full timeWe are a hybrid, remote-office company dedicated to growing our talent anywhereWe have onsite locations in: Sioux Falls, SD, Scottsdale, AZ, Troy, MI, Franklin, TN, Dallas, TXAt Pathward, we take tremendous pride in our purpose to create financial inclusion for allTM. We are a financial empowerment company that works with innovators to increase financial...
-
RN-Status Review Specialist
2 weeks ago
Remote, Oregon, United States SSM Health Full timeIt's more than a career, it's a callingMO-REMOTEWorker Type:RegularJob Highlights:Department: Status ReviewSchedule: Full Time, Evening Shift, 3pm-11:30pm; Monday-FridayStarting Pay: $32.58+ (Offers are based on years of experience and equity for this role.)Location: Remote (candidate must live in IL, MO, OK, or WI)Candidate must have inpatient RN...
-
Live Scan Review Specialist
2 months ago
Remote, Oregon, United States Dandy Full timeDandy is transforming the massive ($200B) but antiquated dental industry. Backed by some of the world's leading venture capital investors, we are on an ambitious mission to integrate and simplify every function of the dental practice through technology. By building the operating system for every dental office in America, Dandy is empowering dentists with...
-
RN-Utilization Review
2 weeks ago
Remote, Oregon, United States SSM Health Full timeIt's more than a career, it's a callingWI-REMOTEWorker Type:RegularJob Highlights:Department: Utilization ReviewSchedule: Full Time, Day Shift, 8:30am-5:00pm; every 3rd weekend rotationStarting Pay: $67, annually (Offers are based on years of experience and equity for this role.)Location: WI Remote (candidate must live in IL, MO, OK, or WI)Candidate...
-
RN-Utilization Review
2 weeks ago
Remote, Oregon, United States SSM Health Full timeIt's more than a career, it's a callingMO-REMOTEWorker Type:RegularJob Highlights:Department: Utilization ReviewSchedule: Full Time, Day Shift, 8:00am-4:30pm; no weekendsStarting Pay: $67, annually (Offers are based on years of experience and equity for this role.)Location: Remote (candidate must live in IL, MO, OK, or WI)Candidate must have inpatient...
-
RN-Utilization Review
2 weeks ago
Remote, Oregon, United States SSM Health Full timeIt's more than a career, it's a callingWI-REMOTEWorker Type:RegularJob Highlights:Department: Utilization ReviewSchedule: Part Time, Day Shift, 8:30am-5:00pm; every 3rd weekend rotationStarting Pay: $32.58+ (Offers are based on years of experience and equity for this role.)Location: WI Remote (candidate must live in IL, MO, OK, or WI)Candidate must...
-
Compliance Specialist II
2 months ago
Remote, Oregon, United States Life Technologies (Thermo Fisher Scientific) Full timeWork ScheduleOtherEnvironmental ConditionsOffice Job Description The Compliance Specialist is responsible for ensuring full compliance with US and international regulations by supporting the LSG Thermofisher trade compliance group in the daily management, of global free trade agreements and their impact on the overall business of the division. The specialist...
-
Coding Specialist
2 months ago
Remote, Oregon, United States Iodine Software Full timeInpatient Coding Specialist Join us. Let's make a direct impact in healthcare. Being an Iodine employee means becoming part of something bigger: using clinical AI technology to drive smarter healthcare processes and positively impact patient care. Who we are: Iodine is an enterprise AI company that is championing a radical rethink of how to create value...
-
Site Care Partner
2 months ago
Remote, Oregon, United States Parexel Full timeParexel FSP is hiring multiple Site Care Partners across the US--these are great opportunities for experienced CRAs seeking career advancementJob Summary The Site Care Partner is the main client point of contact for investigative sites throughout a study life cycle; accountable for site start-up activities through activation; accountable for building and...
-
Medical Payment Posting Specialist
2 months ago
Remote, Oregon, United States pMD Full timeWe hold ourselves to exceptionally high standards in order to provide unparalleled service to healthcare professionals, their staff and patients. We strive to end each workday knowing that we've made someone's life better.Our team is comprised of courageous and caring healthcare warriors. We're here to solve the impossible problems, such as reducing medical...
-
Security Specialist Sr
2 months ago
Remote, Oregon, United States The PNC Financial Services Group Full timeJob ProfilePosition OverviewAt PNC, our people are our greatest differentiator and competitive advantage in the markets we serve. We are all united in delivering the best experience for our customers. We work together each day to foster an inclusive workplace culture where all of our employees feel respected, valued and have an opportunity to contribute to...
-
Deal Desk Specialist
3 weeks ago
Remote, Oregon, United States Restaurant365 Full timeRestaurant365 is a SaaS company disrupting the restaurant industry Our cloud-based platform provides a unique, centralized solution for accounting and back-office operations for restaurants. Restaurant365's culture is focused on empowering team members to produce top-notch results while elevating their skills. We're constantly evolving and improving to make...
-
Senior AR Billing Specialist
3 weeks ago
Remote, Oregon, United States Restaurant365 Full timeRestaurant365 is a SaaS company disrupting the restaurant industry Our cloud-based platform provides a unique, centralized solution for accounting and back-office operations for restaurants. Restaurant365's culture is focused on empowering team members to produce top-notch results while elevating their skills. We're constantly evolving and improving to make...
-
Sales Operation Specialist II
2 weeks ago
Remote, Oregon, United States D-Wave Systems Full timeWHAT WE NEED: Sales Operations Specialist II WHERE: Remote US WHO WE ARE: D-Wave (NYSE: QBTS) a leader in the development and delivery of quantum computing systems, software, and services, and is the world's first commercial supplier of quantum computers—and the only company building both annealing quantum computers and gate-model quantum computers. Our...
-
Impound Specialist I
1 week ago
Remote, Oregon, United States Exeter Finance Full timeAt Exeter Finance, we are committed to helping customers find the right financing for their next vehicle purchase. By building strong relationships with our customers and network of dealer partners we are able to give options that make sense, getting customers behind the wheel of their car.Every team member is integral to our success. Whether you're at a...
-
RCDD/Telecom Technical Specialist
2 weeks ago
Remote, Oregon, United States Larson Design Group Full timeAbout UsLarson Design Group (LDG) is an award-winning, employee-owned Architecture, Engineering, and Consulting Firm. Guided by our core values, we're expanding our team, opening new offices, and adding new offerings to provide responsive, innovative solutions to clients nationwide. Being 100% employee-owned directly impacts our culture: it drives our...