Talent.com
MMS
Nonclinical WriterMMS • Boston, MA, US
Nonclinical Writer

Nonclinical Writer

MMS • Boston, MA, US
30+ days ago
Job type
  • Full-time
  • Quick Apply
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 Powered by JazzHR
Create a job alert for this search

Nonclinical Writer • Boston, MA, US

Similar jobs

Senior Medical Writer (Remote) at MMS Boston, MA

Itlearn360Salem, MA, United States
Remote
Full-time

OverviewSenior Medical Writer (Remote) job at MMS.About MMSMMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific ... Show more

 • Promoted

Remote Senior Technical Writer -- IVD & Medical Devices Job at Daley And Associat

Daley And Associates, LLCBoston, MA, United States
Remote
Temporary

A growing Med Device company is seeking a detail-oriented Technical Writer for a 6-month contract position.This role involves creating clear and accurate scientific documentation, ensuring complian... Show more

 • Promoted

Medical Writer - Nursing & Health Professions (Remote) Job at EBSCO Information

EBSCO Information ServicesBoston, MA, United States
Remote
Full-time

A leading research services provider is seeking a Medical Writer to develop evidence-based content for nursing and health professions.This role requires strong writing skills and a solid understand... Show more

 • Promoted

Volunteer Remote Grant Researcher and Writer

MatchingDonorsCanton, MA, United States
Remote
Full-time

Volunteer Grant Researcher and Writer MatchingDonors.Volunteer Grant Researcher and Writer ! This is a flexible and rewarding remote volunteer opportunity which can fit your lifestyle.Your efforts ... Show more

 • Promoted

Travel Nurse RN - Infusion - $2,200 to $2,719 per week in Beverly, MA

TravelNurseSourceBeverly, MA, US
$2,200.00 weekly
Full-time +1

Registered Nurse (RN) | Infusion.TravelNurseSource is working with Lancesoft Inc to find a qualified Infusion RN in Beverly, Massachusetts, 01915!.Established in 2000, LanceSoft is a Certified MBE ... Show more

 • Promoted

Proposal Writer

ClariMed, Inc.Boston, MA, United States
Full-time

ClariMed is a human-centered development and regulatory practice for medical products developed by pharmaceutical and medical device manufacturers.Our best-of-breed professional services cultivate ... Show more

 • Promoted

Scientific Writer (Onsite Consultant)

NanobiosymCambridge, MA, USA
$70,000.00 yearly
Full-time
Quick Apply

Scientific Writer (Onsite Consultant).The ideal candidate will have a.PhD or Master's degree in a science discipline.Help frame, edit, and refine scientific manuscripts, white papers, technical bri... Show more

Technical Writer (Hybrid / Remote)

ComriseAndover, MA, United States
Remote
Full-time

Location :Newton, MA (Hybrid or 90% Remote - open to nearby states NH, VT, and ME)Duration :12-month ContractPay Rate :$65-$100 / hour on W2 (negotiable depending on experience)Hours :9AM to 5PMSum... Show more

 • Promoted

Licensed Clinical Social Worker (LCSW)

HeadwayBoston, MA, US
Full-time

Licensed Clinical Social Worker (LCSW).Licensed Clinical Social Worker  — Are you ready to launch or expand your private practice? .Headway is here to help you start accepting insurance with ease, ... Show more

 • Promoted

Junior Writer - Remote

TradeJobsWorkForce02474 Arlington, MA, US
Remote
Full-time

Junior Writer Job Duties: • Create effective and compelling copy • Write clear, concise a... Show more

 • Promoted

Senior Specifications Writer - Remote Opportunity

JCJ ARCHITECTUREBoston, MA, United States
Remote
Full-time

A leading architecture firm is seeking a Principal / Lead Interior Designer to manage project specifications and support technical needs.The ideal candidate will have significant experience in arch... Show more

 • Promoted

Associate Director, Quantitative Clinical Pharmacology (QCP) Lead

Takeda PharmaceuticalBoston, MA, US
Full-time

By clicking the “Apply” button, I understand that my employment application process with Takeda will commence and that the information I provide in my application will be processed in line with Tak... Show more

 • Promoted

Training Content Writer

SkillBoston, Massachusetts, United States
Temporary

Our Canada based learning and development client is looking for a Training Content Writer to join for ongoing project to project work.Job Role: Training Content Writer.Our client is looking to buil... Show more

 • Promoted

Life Sciences Underwriter - Boston

The Hartford Financial Services Group, Inc.Boston, MA, United States
Full-time

Join a high-performing, collaborative team within our Boston Life Sciences underwriting team, where innovation and strategic thinking drive success.We're seeking a skilled Life Sciences Underwriter... Show more

 • Promoted

Travel CT Tech - $2,858 per week in Brockton, MA

AlliedTravelCareersBrockton, MA, US
$2,858.00 weekly
Full-time

AlliedTravelCareers is working with Advantis Medical Staffing to find a qualified CT Tech in Brockton, Massachusetts, 02301!.Advantis Medical, the #1 rated travel nurse agency, is currently seeking... Show more

 • Promoted

Medical Oncologist

HealthEcareers - ClientBrockton, MA, USA
Full-time

The Division of Hematology and Oncology at Beth Israel Deaconess Medical Center (BIDMC) and Signature Healthcare & Brockton Hospital is recruiting for a board certified/board eligible full-time com... Show more

 • Promoted

Clinical Director - SOTP

VitalCore Health StrategiesBridgewater, MA, US
Full-time

Join the VitalCore Team in Massachusetts!.We’re people who are fueled by passion, not by profit.VitalCore Health Strategies (VCHS), an industry leader in Correctional Health Care has an opening for... Show more

 • Promoted

AVP, Product Services / RFP Writer

The TCW GroupBoston, MA, United States
Full-time

TCW is a leading global asset management firm with a strong foundation across Fixed Income, Private Credit & Alternatives, and Equities.We are committed to delivering exceptional client outcomes th... Show more

 • Promoted

Senior Medical Writer - Regulatory & Post-Market (Remote)

Philips InternationalCambridge, MA, United States
Remote
Full-time

A leading health technology company is looking for a Medical Writer to support clinical and post-market documentation.This role will involve authoring technical documents, ensuring compliance with ... Show more

 • Promoted

Eacademy Sanofi is hiring: Remote Principal Medical Writer & Regulatory Lead in

Eacademy SanofiBoston, MA, United States
Remote
Full-time

A major healthcare organization is seeking a Principal Medical Writer Associate Director to lead the development of regulatory-compliant clinical documents.The ideal candidate will have over six ye... Show more