Senior Medical Writing Consultant - Europe Regulatory and MW - Regulatory Submissions Writing ITALY

MMS Holdings Inc; Frosinone; In loco; EUR 40.000 - 65.000; Tempo pieno

Descrizione del lavoro

A data-focused CRO in Italy is seeking a full-time Medical Writer to evaluate medical literature and write clinical documents. The ideal candidate has 3-5 years of regulatory and clinical medical writing experience, with strong organizational and writing skills. This role offers the opportunity to work independently with clients and mentor other writers. Join a recognized leader in the industry with a commitment to scientific rigor and customer satisfaction.

Competenze

• At least 3 years of previous experience in the pharmaceutical industry.
• 3-5 years of industry regulatory and clinical medical writing experience is a must.
• Substantial clinical study protocol experience as a lead author is required.

Mansioni

• Evaluate, analyze, and interpret medical literature for study design and scientific rigor.
• Write and edit clinical development documents.
• Maintain timelines and workflow of writing assignments.

Conoscenze

Exceptional writing skills

Excellent organizational skills

Understanding of clinical data

Proficient in MS Word, Excel, PowerPoint

Strong communication skills

Formazione

Bachelor's, Master's, or Ph.D. in a scientific, medical, or clinical discipline

Strumenti

MS Word

Excel

PowerPoint

Descrizione del lavoro

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 in Global Health & Pharma’s international 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 team!

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 clients to coordinate all facets of projects; possess competent communication skills for projects.
• Contribute substantially to, or manage, the production of interpretive guides.
• Take ownership of assignments, proactively consulting with project team members and other departments as needed.
• Mentor medical writers and other project team members involved in the writing process.

Requirements

• At least 3 years of previous experience in the pharmaceutical industry.
• Must have 3-5 years of industry regulatory and clinical medical writing experience.
• Hold a Bachelor's, Master's, or Ph.D. in a scientific, medical, or clinical discipline.
• Substantial clinical study protocol experience as a lead author is required.
• Experience leading and managing teams while authoring regulatory documents with aggressive timelines.
• Experience in regulatory submissions (clinical study reports) presented to authorities is a plus.
• Understanding of clinical data.
• Exceptional writing skills.
• Excellent organizational skills and ability to multi-task.
• Expert in MS Word, Excel, PowerPoint, and related tools.
• Experience as a project lead or managing a project team.
• Strong understanding of federal regulations, GCP, and ICH guidelines is a plus.
• Experience with orphan drug designations and PSP/PIPs is a plus (not required).

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