Senior Medical Writer (Protocols) - Remote Job at MMS, Baltimore, MD

cERBVEx4VG5qV1l1SWVja2VFdVI3TCtVU3c9PQ==
  • MMS
  • Baltimore, MD

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, mostly focusing on clinical protocols but the overall role may include, but is not limited to, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Module 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5 documents, 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 and 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

Wipro

Senior full stack dot net developer Job at Wipro

 ...Wipro Limited (NYSE: WIT, BSE: 507685, NSE: WIPRO) is a leading technology services and consulting company focused on building innovative solutions that address clients' most complex digital transformation needs. Leveraging our holistic portfolio of capabilities in consulting... 

ACCEL BI CORPORATION

MS Dynamics Developer Job at ACCEL BI CORPORATION

MS Dynamics Developer Location Seattle, WA (Downtown area) : Benefits: ~401(k) matching ~ Paid time off We seek a talented and...  ...configuration, and development. Knowledge of Dynamics 365, Dynamics CRM, or other Dynamics platforms. Experience with programming... 

Polygon Labs

Chief of Staff - CEO Job at Polygon Labs

 ...Polygon zkEVM, and Polygon Miden, which is in development as well as Polygon CDK. Your Role We are seeking an experienced Chief of Staff to support and work alongside the CEO in their day-to-day activities. As a Chief of Staff, you will work closely with the... 

University of Kentucky

Security Officer | University of Kentucky Job at University of Kentucky

 ...Department Name: 3HL00:UK Police Job Summary: The University of Kentucky Police Department prioritizes its investment of professional...  ...and offer a competitive starting pay of $17.50/hour for Security Officers. We are looking for individuals who are eager to grow... 

Global Guardian

Global Security Operations Analyst Job at Global Guardian

 ...Global Guardian is a leading provider of emergency medical and security solutions for corporations and individuals. Our 24/7 Operations...  ...intelligence monitoring, and assisting clients under duress traveling overseas. The GSOC Operator will report directly to the Operations...