Medical Writer for Clinical Development Documents

2 settimane fa


Roma, Lazio, Italia Mms Holdings Inc A tempo pieno

Job Title: Senior Medical Writing Consultant
About Us: MMS Holdings Inc 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. We have a global footprint across four continents and maintain a 97 percent customer satisfaction rating.

Job Description:
We are looking for a full-time Senior Medical Writing Consultant to join our extended team. As a Senior Medical Writing Consultant, you 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. You will write and edit clinical development documents, including clinical protocols, investigator's brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, presentation materials, and publications to medical journals. You will also maintain timelines and workflow of writing assignments, practice good internal and external customer service, and interact directly and independently with clients to coordinate all facets of projects.

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 Bachelor's, Master's, or Ph.D. in a scientific, medical, or clinical discipline. Substantial clinical study protocol experience, as lead author, is required. Experience leading and managing teams while authoring regulatory documents with aggressive timelines is also required. Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines is a plus.



  • Roma, Lazio, Italia Syneos Health A tempo pieno

    Job Title: Principal Medical WriterWe are seeking a highly skilled Principal Medical Writer to join our IAI Medical Writing Team at Syneos Health. As a key member of our team, you will be responsible for developing clinical documents for submissions to regulatory authorities globally.Key Responsibilities:Develop scientifically valid, complete, and consistent...


  • Roma, Lazio, Italia Trilogywriting A tempo pieno

    About the RoleWe are seeking a Senior/Principal Medical Writer to join our team at Trilogy Writing & Consulting. As a Senior/Principal Medical Writer, you will be responsible for preparing clinical regulatory documents, including Clinical Study Protocols, Clinical Study Reports, and Investigator Brochures. You will work collaboratively with client authoring...

  • Senior Medical Writer

    4 settimane fa


    Roma, Lazio, Italia Trilogy Writing and Consulting A tempo pieno

    Job Title: Senior/Principal Medical WriterCompany: Trilogy Writing & ConsultingWe are seeking a highly skilled Senior/Principal Medical Writer to join our team at Trilogy Writing & Consulting. As a Senior/Principal Medical Writer, you will be responsible for preparing clinical regulatory documents, including Clinical Study Protocols, Clinical Study Reports,...

  • Senior Clinical Writer

    2 settimane fa


    Roma, Lazio, Italia MMS Holdings Inc A tempo pieno

    About the RoleMMS Holdings Inc is seeking a dedicated and experienced Medical Writing Consultant to join our team. As a key member of our clinical operations team, you will be responsible for creating high-quality clinical documents, including clinical protocols, investigator's brochures, and clinical study reports.Key ResponsibilitiesEvaluate and analyze...


  • Roma, Lazio, Italia Mms Holdings Inc A tempo pieno

    Medical Writer - Regulatory AffairsMMS Holdings Inc is a leading Contract Research Organization (CRO) that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges.As a Medical Writer - Regulatory Affairs, you will be responsible for critically...


  • Roma, Lazio, Italia MMS Holdings Inc. A tempo pieno

    MMS Holdings Inc. is a leading Contract Research Organization (CRO) that supports the pharmaceutical, biotech, and medical device industries with a data-driven approach to complex trial data and regulatory submission challenges.Key Responsibilities:Critically evaluate, analyze, and interpret medical literature to select primary resource materials for study...


  • Roma, Lazio, Italia Mms Holdings Inc A tempo pieno

    About Mms Holdings IncMms Holdings Inc is a leading Contract Research Organization (CRO) that provides innovative, data-focused solutions to the pharmaceutical, biotech, and medical device industries.Job DescriptionWe are seeking a highly skilled Medical Writer to join our team. As a Medical Writer, you will be responsible for critically evaluating,...


  • Roma, Lazio, Italia MMS Holdings Inc. A tempo pieno

    MMS Holdings Inc. is a leading Contract Research Organization (CRO) that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges.We are seeking a highly skilled Regulatory Medical Writer to join our team.Responsibilities:Under minimal supervision, the...


  • Roma, Lazio, Italia MMS Holdings Inc. A tempo pieno

    MMS Holdings Inc. is a leading Contract Research Organization (CRO) that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges.We are seeking a highly skilled Medical Writer to join our team. The ideal candidate will have a strong background in...


  • Roma, Lazio, Italia MMS Holdings Inc. A tempo pieno

    MMS Holdings Inc. is a leading Contract Research Organization (CRO) that provides innovative data-focused services to the pharmaceutical, biotech, and medical device industries. We are seeking a highly skilled Senior Medical Writing Consultant to join our team.The ideal candidate will have a strong background in regulatory writing and clinical medical...


  • Roma, Lazio, Italia MMS Holdings Inc. A tempo pieno

    MMS Holdings Inc. is a leading Contract Research Organization (CRO) that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges.We are seeking a highly skilled and experienced Regulatory Document Specialist to join our team.Responsibilities:Under...


  • Roma, Lazio, Italia MMS Holdings Inc. A tempo pieno

    MMS Holdings Inc. is a leading provider of clinical data solutions for the pharmaceutical industry. As a Senior Medical Writing Consultant, you will play a crucial role in our team, helping to deliver high-quality clinical documents to our clients.Key Responsibilities:Develop and maintain a deep understanding of regulatory requirements and industry standards...


  • Roma, Lazio, Italia SGS A tempo pieno

    Job DescriptionAs a key member of the clinical team at SGS, you will play a crucial role in ensuring the safety and efficacy of in-vitro diagnostic medical devices available in Europe. Your primary responsibility will be to act as a key decision maker in ensuring that IVD devices sold in the EU provide relevant clinical benefits, minimize risks to patients,...


  • Roma, Lazio, Italia Mms A tempo pieno

    Job Title: Senior Medical Writing ConsultantAbout the Role: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...


  • Roma, Lazio, Italia Syneos Health A tempo pieno

    Job SummaryWe are seeking a highly skilled Senior Clinical Document Developer to join our team at Syneos Health. As a key member of our IAI Medical Writing Team, you will be responsible for developing clinical documents for submissions to regulatory authorities globally.Key ResponsibilitiesDevelop scientifically valid, complete, and consistent clinical...

  • Medical Writing Manager

    4 settimane fa


    Roma, Lazio, Italia Johnson & Johnson A tempo pieno

    Job Title: Medical Writing Manager - Oncology RegulatoryJob Summary:We are seeking a highly skilled Medical Writing Manager to join our Oncology Regulatory team at Johnson & Johnson Innovative Medicine. As a Medical Writing Manager, you will be responsible for leading a team of medical writers in the preparation and finalization of clinical documents.Key...


  • Roma, Lazio, Italia Mms A tempo pieno

    About MMSMMS is a leading Contract Research Organization (CRO) supporting the pharmaceutical, biotech, and medical device industries with a proven approach to complex trial data and regulatory submission challenges. With a global presence and a 97% customer satisfaction rating, MMS has been recognized as a top CRO in Global Health & Pharma's international...


  • Roma, Lazio, Italia BTG A tempo pieno

    Job Summary: We are seeking a Strategic Clinical Affairs Director for EMEA Region to lead our clinical affairs strategy for the EMEA region. As a key member of our team, you will be responsible for developing and executing a comprehensive clinical affairs strategy that aligns with our global objectives.The successful candidate will have a deep understanding...


  • Roma, Lazio, Italia MAI Fortrea Development Limited A tempo pieno

    As a leading global contract research organization (CRO) with a passion for scientific rigor and decades of clinical development experience, Fortrea provides pharmaceutical, biotechnology, and medical device customers a wide range of clinical development, patient access and technology solutions across more than 20 therapeutic areas.Senior Clinical Data...


  • Roma, Lazio, Italia EUSA Pharma A tempo pieno

    Job Title: Medical Affairs Publications ManagerAt EUSA Pharma, we are seeking a highly skilled and experienced Medical Affairs Publications Manager to join our team. As a key member of our Medical Affairs department, you will be responsible for overseeing the development and implementation of publication plans for global and local clinical studies and...