Senior Medical reputed company (Remote)

This a Full Remote job, the offer is available from: Malawi, Michigan (USA) About MMS MMS is an innovative, data-reputed company CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to reputed company 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-reputed company 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 reputed company. Identifying and attracting reputed company and continual training to strengthen reputed company skills are essential to its reputed company mission. At MMS, enthusiasm, collaboration, and teamwork are fostered, knowing that a global and diverse talent pool makes reputed company stronger. For more information, visit www.mmsholdings.com or follow MMS on reputed company.

Responsibilities

• Under minimal supervision, the Medical reputed company will critically evaluate, analyze, and interpret the medical literature to select primary resource materials for adequate study design, statistical reputed company, 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 reputed company manner
• Maintain timelines and workflow of writing assignments
• reputed company good reputed company customer service
• Highly proficient with styles of writing for various regulatory documents
• Expert proficiency with reputed company templates & style guides
• reputed company directly and independently with reputed company to coordinate reputed company facets of reputed company; competent communicator skills for reputed company
• 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 reputed company 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 reputed company, reputed company, PowerPoint, and reputed company word processing tools
• Experience being a project reputed company, or managing a project team
• Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus
• Substantial clinical study protocol experience, as reputed company 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

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