Senior Medical Writer Remote
Senior Medical Writer Remote
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Job Description
MMS is an innovative datafocused 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 technologyenabled services and a datadriven 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 inGlobal Health & Pharmasinternational awards programs for the last three consecutive years. For more information visit www.mmsholdings 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 investigators 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
- At least 3 years of previous experience in the pharmaceutical industry
- Must have at least 35 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 multitask 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
Required Experience:
Senior IC
Employment Type
Full-Time
