Senior Medical Writing Consultant
2 giorni fa
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.We are looking for full time consultants interested in joining our extended teamResponsibilitiesUnder 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 biasWrite 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 journalsComplete writing assignments in a timely mannerMaintain timelines and workflow of writing assignmentsPractice good internal and external customer serviceHighly proficient with styles of writing for various regulatory documentsExpert proficiency with client templates & style guidesInteract directly and independently with client to coordinate all facets of projects; competent communicator skills for projectsContribute substantially to, or manages, production of interpretive guidesTake ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance as necessaryMentor medical writers and other members of the project team who are involved in the writing processRequirementsAt least 3 years of previous experience in the pharmaceutical industryMust have at least 3-5 years of industry regulatory writing and clinical medical writing experienceThe ideal candidate would hold a Bachelors, Masters, or Ph.D. in scientific, medical, clinical disciplineSubstantial clinical study protocol experience, as lead author, requiredExperience leading and managing teams while authoring regulatory documents with aggressive timelinesExperience in regulatory submissions (clinical study reports) presented to regulatory authorities a plusUnderstanding of clinical dataExceptional writing skills are a mustExcellent organizational skills and the ability to multi-task are essential prerequisitesCandidate must be an expert in MS Word, Excel, PowerPoint, and related word processing toolsExperience being a project lead, or managing a project teamStrong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plusSubstantial clinical study protocol experience, as lead author, requiredExperience leading and managing teams while authoring regulatory documents with aggressive timelinesNot required, but experience with orphan drug designations and PSP/PIPs a plus#J-*****-Ljbffr
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Senior Medical Writing Consultant
2 settimane fa
Lazio, Italia Kyndryl A tempo pienoSenior Medical Writing Consultant - Europe MMS Holdings IncRomaEUR ***************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...
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Senior Medical Writing Consultant
7 giorni fa
Lazio, Italia Mms Holdings Inc. A tempo pienoMMS 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...
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Senior Medical Writing Consultant
1 settimana fa
Lazio, Italia Mms A tempo pienoMMS 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...
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Senior Medical Writing Consultant
1 settimana fa
Lazio, Italia Mms Holdings Inc A tempo pienoMMS 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...
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Scientific Writing Lead
1 settimana fa
Lazio, Italia Altro A tempo pienoScientific Writing Lead (Italian Speaking)We are a technology-led healthcare solutions provider.We are driven by our purpose to enable healthcare organizations be future ready.We offer accelerated, global growth opportunities for talent that's bold, industrious, and nimble.With Indegene, you gain a unique career experience that celebrates entrepreneurship,...
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Scientific Writing Lead
2 settimane fa
Lazio, Italia Indegene A tempo pienoJob Title: Scientific Writing Lead (Italian Speaking)Who are we?We are a technology-led healthcare solutions provider.We are driven by our purpose to enable healthcare organizations be future ready.We offer accelerated, global growth opportunities for talent that's bold, industrious, and nimble.With Indegene, you gain a unique career experience that...
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Scientific Writing Lead
2 settimane fa
Lazio, Italia Indegene A tempo pienoJob Title: Scientific Writing Lead (Italian Speaking)Who are we?We are a technology-led healthcare solutions provider. We are driven by our purpose to enable healthcare organizations be future ready. We offer accelerated, global growth opportunities for talent that's bold, industrious, and nimble. With Indegene, you gain a unique career experience that...
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Scientific Writing Lead
2 giorni fa
Lazio, Italia Indegene A tempo pienoJob Title: Scientific Writing Lead (Italian Speaking) Who are we?We are a technology-led healthcare solutions provider.We are driven by our purpose to enable healthcare organizations be future ready.We offer accelerated, global growth opportunities for talent that's bold, industrious, and nimble.With Indegene, you gain a unique career experience that...
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Medical Writer
3 giorni fa
Lazio, Italia Mms Holdings Inc. A tempo pienoMMS 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...
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Senior Consultant
1 settimana fa
Lazio, Italia Altro A tempo pienoOverview The Senior Consultant will work closely with the Partner and the Director of the relevant practice of the firm.In particular, they will manage projects of advocacy, lobbying and coalition building.The Senior Consultant is required to monitor the legislative, regulatory and policy activity of the main Italian government bodies and regulatory...
