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Report writer Jobs in Raleigh, NC

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Report writer • raleigh nc

Last updated: 3 days ago
Nonclinical Writer

Nonclinical Writer

MMSRaleigh, NC, US
Full-time
Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical resea...Show moreLast updated: 30+ days ago
Proposal Writer- Remote

Proposal Writer- Remote

SharecareRaleigh, NC, United States
Remote
Full-time
Job Description Sharecare is the leading digital health company that helps people – no matter where they are in their health journey – unify and manage all their health in one place.Our comprehensi...Show moreLast updated: 30+ days ago
Copywriter / Content Writer (Intern - Remote)

Copywriter / Content Writer (Intern - Remote)

Venubi, Incorporated.Cary, NC, United States
Remote
Full-time
We're looking for a skilled content writer to work with teams across the company and craft valuable content that will educate our customers and wow our prospects. Your work will have you fiddling wi...Show moreLast updated: 5 days ago
Curriculum Writer

Curriculum Writer

Charlie HealthRaleigh, NC, US
Full-time
Millions of people across the country are navigating mental health conditions, substance use disorders, and eating disorders, but too often, they're met with barriers to care.From limited local...Show moreLast updated: 30+ days ago
Senior Technical Writer

Senior Technical Writer

ContiemCary, NC, US
Full-time
The final compensation offer will be determined by factors such as the candidate's skills, qualifications, experience, geographic location, and other relevant factors.We aim to be the leading p...Show moreLast updated: 30+ days ago
Medical Safety Writer

Medical Safety Writer

CHIESI USACary, NC
Full-time
We want to be recognized as an international group focused on research, able to develop and commercialize innovative therapeutic solutions to improve the quality of people's lives.We intend to main...Show moreLast updated: 30+ days ago
Mechanical Service Writer

Mechanical Service Writer

Snider Fleet SolutionsRaleigh, NC, US
Full-time
People who want to do a great job want to work for a company that values that dedication.Snider Fleet Solutions is one of the largest commercial tire dealers and retread service providers in the na...Show moreLast updated: 30+ days ago
Technical Writer

Technical Writer

omega solutions incraleigh, North Carolina, United States
Full-time
Raleigh, NC The IT Trainer / Technical Writer is tasked with documentation of training materials in support of the DIT transition to ServiceNow and the procedural documentation of Standard Pre-Appro...Show moreLast updated: 30+ days ago
DHB / NC HIEA APD Writer

DHB / NC HIEA APD Writer

V-Soft ConsultingRaleigh, NC, United States
Full-time
Primary Location : Raleigh, North Carolina.V-Soft Consulting is currently hiring for a.Prior experience developing APDs or related documents (e. Working knowledge of government regulations as they pe...Show moreLast updated: 30+ days ago
Technical Writer

Technical Writer

AlphanumericRaleigh, NC, US
Full-time
Remote - must reside in one of the following states : CO, CT, DE, FL, GA, IL, MA, MD, MO, NC, NE, NJ, NY, NV, PA, SC, TN, TX, VA, or WV. Must be eligible to work in the U.No C2C or 3rd-party submissi...Show moreLast updated: 30+ days ago
NCDOR - Technical Writer- Expert

NCDOR - Technical Writer- Expert

InstantServe LLCRaleigh, NC, United States
Full-time
This position is required to provide temporary assistance with design, development, and implementation of policies, procedures, and overarching training materials for Information Technology staff r...Show moreLast updated: 6 days ago
Automotive Service Writer / Advisor

Automotive Service Writer / Advisor

NC AutohausRaleigh, NC, US
Full-time
Now Hiring : A Certified Rock Star (Service Advisor).Autohaus Import Service – Raleigh, NC.Are You the Headliner We've Been Waiting For? ??. Hey there, I’m Doug Rogers.My wife and I o...Show moreLast updated: 3 days ago
Technical Specialist / Technical Writer

Technical Specialist / Technical Writer

My3Tech IncRaleigh, NC, United States
Full-time
Job : Technical Specialist- Mid Level.Location : NC DHHS, Raleigh NC.NCDHHS is seeking a contractor to provide Advanced Planning development, support and other documentation required for the plannin...Show moreLast updated: 6 days ago
Principal Medical Writer- FSP

Principal Medical Writer- FSP

PAREXELRaleigh, NC, United States
Full-time
Parexel FSP is looking for a Principal Medical Writer! This is a remote role anywhere in the United States or Canada.The Medical Writer, Medical Writing, is responsible for writing and overseeing t...Show moreLast updated: 5 days ago
BI Report Developer

BI Report Developer

VirtualVocationsRaleigh, North Carolina, United States
Full-time
A company is looking for a BI Report Developer 1.Key Responsibilities Designs, develops, and maintains business intelligence reports and dashboards Collaborates with stakeholders to understand r...Show moreLast updated: 4 days ago
Keynote Technical Writer

Keynote Technical Writer

Eliassen GroupRaleigh, NC, United States
Full-time
We are seeking a skilled and creative.This role bridges the gap between complex technical concepts and effective storytelling, transforming verbal content into clear, polished, and impactful presen...Show moreLast updated: 6 days ago
Technical Writer

Technical Writer

Cynet SystemsRaleigh, NC, United States
Full-time
This position will support the IT Business Transformation Analyst in the design and development of policies, procedures, and overarching training for Information Technology staff.The primary focus ...Show moreLast updated: 6 days ago
  • Promoted
Freelance Writer

Freelance Writer

OutlierRaleigh, NC, United States
Full-time
Earn up to $15 / hour + performance bonuses.Outlier, a platform owned and operated by Scale AI, is looking for.If you're passionate about improving models and excited by the future of AI, this is you...Show moreLast updated: 4 days ago
Technical Writer

Technical Writer

ITWRaleigh, NC, United States
Full-time
Alpine, an ITW company, provides a suite of proprietary software, engineering services, and equipment that enables our customers to design, engineer, and fabricate structural building components (t...Show moreLast updated: 30+ days ago
People also ask
Nonclinical Writer

Nonclinical Writer

MMSRaleigh, NC, US
30+ days ago
Job type
  • Full-time
Job description

Job Description

Job Description

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.

Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit  www.mmsholdings.com  or follow MMS on LinkedIn.

This person will participate in the development, writing, and management of highly technical nonclinical documents. This is a full-time, remote position.

Roles and Responsibilities :

  • Strong experience with development and writing of nonclinical documents (eg, Module 2.4 and 2.6 eCTD submission documents, Investigator’s Brochure [IB], Nonclinical Study Reports, Meeting Requests, Briefing Documents, RTQs)
  • Lead projects independently with minimal oversight, lead the writing (structure, content and messaging) of nonclinical documents, ensure the nonclinical package aligns with current regulatory guidelines and meets scientific integrity
  • Ability to author based on highly technical sources such as GLP and non-GLP nonclinical study reports, in vivo and in vitro nonclinical data
  • Ability to develop a mapping plan for the placement of nonclinical studies within structure of Module 2.4 and 2.6 eCTD submission documents
  • Interpret and analyze applicable pharmacokinetics, pharmacology, and toxicology data (eg, Prism files, bioanalytical reports, clinical pathology reports, PK / TK evaluation reports)
  • Collaborate with cross-functional teams such as project management, safety, efficacy, biostats, regulatory operations, and CMC
  • Demonstrated ability to lead others to complete complex projects
  • Ability to complete documents according to sponsor’s format, processes, and according to regulatory guidelines
  • Ability to effectively operate in an environment that requires negotiation, persuasion, collaboration, and analytical judgment
  • Organizational expert within the nonclinical subject area
  • Excellent written / oral communication and strong time and project management skills
  • Ability to attend regular team meetings, lead client meeting and CRMs
  • Ability to work in various client systems (eg, SharePoint, Veeva RIM, PleaseReview, EndNote), templates and toolbars
  • Strong understanding of regulatory guidances as it applies to nonclinical submission documents and drug development (eg, ICH, FDA and EMA regulations and guidelines, GLP, GCP, GMP and GDP)

Requirements :

  • BS + in pharmacology, toxicology, biology or chemistry, or related field, with industry experience within regulatory writing, regulatory affairs, laboratory sciences, quality assurance / control
  • Knowledge of GLP, ICH guidelines, and applicable regulatory requirements
  • 2+ years of pharmaceutical regulatory nonclinical writing experience
  • Strong writing and analytical skills
  • Proficiency with MS Office applications.
  • Hands-on experience with clinical trial and pharmaceutical development preferred
  • Basic understanding of CROs and scientific & nonclinical data / terminology, & the drug development process
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