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 inGlobal Health & Pharma’sinternational 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 #J-18808-Ljbffr MMS Holdings Inc
...the capability to make repairs throughout the facilities and resident room units including carpentry, drywall and plaster repairs, painting, plumbing and lighting. Must respond to emergency calls while on duty in any situation pertaining to the safety of staff and...
.... We are truly Pallet Management Made Simple, our workforce is the heart and soul of our business, and we're looking for our next Nailing Machine Operator to join our team! Hourly Pay: $16.00/hr. - $18.00/hr. (depending on experience) Shift(s): Mon-Fri 8:00am...
Security Officer We help make your world a safer place. Securitas is a global company that offers the most advanced and sustainable security solutions in the industry. We are located in 47 countries and have 355,000 employees worldwide and over 150,000 clients. ...
...Responsibilities The candidate will utilize skills and experience in additive manufacturing (AM) to provide guidance to customers on part design and... ...position features three facets: Internal production engineering activities, serving as the subject matter expert ...
...conveyor into drying racks, cardboard boxes or bins containing plastic bags. Packs finished products obtained from drying racks or... ...able to do simple math. 3-6 months experience working in a manufacturing environment preferred. Must be able to read, write and speak...