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Principal Medical Writer

MMS

(Multiple States)

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JOB DETAILS
JOB TYPE
Full-time
SKILLS
Analysis Skills, Biotech and Pharmaceutical, Brochures, Clinical Data, Clinical Practices/Protocols, Clinical Study Publications, Clinical Trial, Communication Skills, Consulting, Contract Research Organization (CRO), Customer Satisfaction, Customer Support/Service, Drug Development, Federal Laws and Regulations, GCP (Good Clinical Practices), ICH Regulations, Informed Consent, Leadership, LinkedIn, Marketing, Medical Equipment, Medical Writing, Mentoring, Microsoft Excel, Microsoft PowerPoint, Microsoft Word, Multitasking, Organizational Skills, Project/Program Management, Publications, Regulations, Regulatory Submissions, Research Protocols, Style Guide, Team Lead/Manager, Team Player, Time Management, Wireless Multimedia Messaging Service, Word Processing, Writing Skills
LOCATION
(Multiple States)
POSTED
30+ days ago
About MMS
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. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating.

Our mission is to deliver high-quality service and technology solutions – rooted in strong science and decades of regulatory experience – that will assist our clients in developing and marketing life-changing therapies to positively improve lives worldwide.

MMS recognizes that a talented staff is what drives our business forward. Identifying and attracting top talent and continual training to strengthen core skills are essential to its core mission. At MMS, enthusiasm, collaboration, and teamwork are fostered, knowing that a global and diverse talent pool makes the company stronger. For more information, visit www.mmsholdings.com 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, 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 & 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
  • Bachelor’s, Masters or PhD Degree in scientific, medical, clinical discipline or related field is required with at least 6 years of previous regulatory writing experience; Masters or PhD degree is preferred
  • 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
  • Not required, but experience with orphan drug designations and PSP/PIPs a plus

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