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

Coastal Pacific Food Distributors

Warehouse Supervisor Job at Coastal Pacific Food Distributors

 ...Logistics jobs are in high demand! CPFD is looking forONE (1)Warehouse Supervisors for our Ontario, CA location. CPFD has been dedicated...  ...Salary : $70,000 - $75,000 per year Schedule : AM Shift - Dry/Chill Building Subject to change based on business needs... 

The MRL Group

Graphic Designer Job at The MRL Group

 ...solutions to our large portfolio of well-known clients. Put simply, we design and produce cool stuff and we will enable you to do the same....  ...and resources effectively ~ Attention to Detail: Exhibits exceptional attention to detail, double-checking all work to ensure... 

OM Software

$23 per hour | Data Entry Clerk/Typist/Remote Support Agent (Full-Time) Job at OM Software

 ...Proficiency in Microsoft Office and Google Suite Ability to work independently and meet deadlines Flexibility to work evenings and weekends as needed Strong attention to detail and ability to maintain a high level of accuracy Proficiency in Microsoft Office and... 

Robert Half

Senior Graphic Designer Job at Robert Half

 ...ideal candidate will be responsible for conceptualizing creative designs for a wide array of media to fit the needs of internal teams...  ...Qualifications ~ Bachelor's degree or equivalent experience in Graphic Design ~6+ years' of creative design experience ~... 

OnSite Healthcare and Wellness, LLC

(NP) Nurse Practitioner - PMHNP or FNP Job at OnSite Healthcare and Wellness, LLC

 ...Quarterly BONUSES *** Our Company OnSite Healthcare and Wellness is a leading Nurse Practitioner (NP) -founded healthcare organization that provides high-level medical and mental health care to patients in Assisted Living (ALF), Independent Living (ILF), Skilled...