Senior Medical Writer (Remote) Job at MMS, New York, NY

cm1SZ3IvQWZDTnlmcFVPR2xGOWpZUkpSaXc9PQ==
  • MMS
  • New York, NY

Job Description

MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO in Global Health & Pharma’s international awards programs for the last three consecutive years. For more information, visit or follow MMS on LinkedIn .

Responsibilities

  • Under minimal supervision, the Medical Writer will critically evaluate, analyze, and interpret the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias
  • Write and edit clinical development documents, including but not limited to, clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, presentation materials and publications to medical journals
  • Complete writing assignments in a timely manner
  • Maintain timelines and workflow of writing assignments
  • Practice good internal and external customer service
  • Highly proficient with styles of writing for various regulatory documents
  • Expert proficiency with client templates & style guides
  • Interact directly and independently with client to coordinate all facets of projects; competent communicator skills for projects
  • Contribute substantially to, or manages, production of interpretive guides
  • Take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance as necessary
  • Mentor medical writers and other members of the project team who are involved in the writing process

Requirements

  • At least 3 years of previous experience in the pharmaceutical industry
  • Must have at least 3-5 years of industry regulatory writing and clinical medical writing experience
  • The ideal candidate would hold a Bachelors, Masters, or Ph.D. in scientific, medical, clinical discipline
  • Substantial clinical study protocol experience, as lead author, required
  • Experience leading and managing teams while authoring regulatory documents with aggressive timelines
  • Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus
  • Understanding of clinical data
  • Exceptional writing skills are a must
  • Excellent organizational skills and the ability to multi-task are essential prerequisites
  • Candidate must be an expert in MS Word, Excel, PowerPoint, and related word processing tools
  • Experience being a project lead, or managing a project team
  • Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus
  • Substantial clinical study protocol experience, as lead author, required
  • Experience leading and managing teams while authoring regulatory documents with aggressive timelines
  • Not required, but experience with orphan drug designations and PSP/PIPs a plus

Job Tags

Remote job, Full time,

Similar Jobs

Amplified Connections, Inc.

Athlete / Sports Minded - Entry Level Marketing Assistant Job at Amplified Connections, Inc.

 ...to apply their athletic background to a marketing career. Our dynamic and high-energy marketing...  ...growth are prioritized. As an Entry Level Marketing Assistant at Amplified Connections...  ...skills. Qualifications: Sports-minded attitude with a passion for teamwork... 

Pets Best Insurance Services, LLC

Customer Service Manager Job at Pets Best Insurance Services, LLC

 ...at an affordable price, Pets Best delivers flexible coverage, an easy claims process, and excellent customer service. As a Customer Care Manager, you will virtually lead a team of Insurance Professionals whose responsibility is to interact with customers on phone, chat... 

SII Group USA

Adobe Magento / Java Senior Developer Job at SII Group USA

Context for one of our customer in the Energy and Industrial Equipment Sector, we are looking to hire on a full-time contract a senior Magento / Java Developer. Your responsibilities Develop and customize Adobe Commerce (Magento) modules and extensions to meet...

AdaptHealth LLC

Medical Equipment Technician Job at AdaptHealth LLC

 ...Perform other related duties as assigned. Requirements: Minimum Job Qualifications: High School Diploma or equivalency Entry level sales, customer service background essential One (1) year of Military, delivery driver with sales component or health care... 

University of Maryland Medical System

Patient Care Technician II Full Time Days Job at University of Maryland Medical System

 ...When we say our community we mean it. Job Description General Summary The Patient Care Technician assists in the delivery of patient care under the direct clinical supervision of the Registered Nurse. Direct care activities are delegated by the Registered...