Senior/Principal Medical Writer
21 ore fa
Trilogy Writing & Consulting, An Indegene Company, is currently looking to hire Senior/Principal Medical Writers (m/w/d) to support our growing company in producing high-quality regulatory documentation for the international pharmaceutical industry. At Trilogy, you will be part of a team that provides a service that goes beyond just writing. Our writers are integral parts of clinical development teams supporting the writing and coordinating of successful documentation across a broad spectrum of therapeutic areas. As a growing company, there is room to develop with us... and your ideas will form our future together. For further insight into who we are and what we do, please see our website ( ). Applicants must live in Italy.
As a Senior/Principal Medical Writer, you will:
Prepare a variety of clinical regulatory documents (Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications) as the lead writer in collaboration with members of client authoring teams and supported by other writers, as appropriate. Ensure that all documents are produced according to agreed timelines, monitor and manage project budgets, adhere to relevant SOPs, and meet the requirements of Trilogy as well as the company's clients. Be responsible for providing document-specific advice to clients. Oversee and coordinate other writers and QC specialists assisting on documents under your responsibility. Project manage the timelines and review cycles of your documents. Work in the client's regulatory document management systems. Candidates must have the following writing experience:
Relevant professional experience actively writing regulatory documents. Worked as the lead writer on at least >3 (Senior Medical Writer) or >5 (Principal Medical Writer) of the following: Clinical Study Protocols, Clinical Study Reports, Clinical Summaries in the CTD format, Investigator Brochures, IMPDs/INDs, scientific publications. For the Principal Medical Writer level, experience in at least 2 different types of CTD dossiers (i.e. full new chemical entity application, a variation, a generic dossier, an orphan drug dossier, a literature-based dossier (e.g. a full-mixed application under Article 8(3) of Directive 2001/83/EC)). Experience interacting directly with clients or authors of the documents and coordinating review cycles, meetings, and project timelines. For the Principal Medical Writer level, ability and willingness to take on any project for which a Lead Writer is needed. Competency in the use of document management systems and review tools. In addition to having the above writing experience, applicants must have:
Diploma/Master's/Bachelor's degree in science/pharmacy (Ph.D. not necessary). Fluent written and spoken English skills. An appreciation for a well-written document and an eye for details. Excellent, proven interpersonal skills, and enjoy proactively participating on a team with diverse personalities. Flexibility and the ability to stay focused under tight timelines. Remuneration will be relative to the level of experience, with all standard Trilogy benefits.
Only candidates who meet the following requirements will be considered:
Applicants will work fully remote from your home office in Italy. Freelancers need not apply. Submission of documents in English including CV and cover letter specifying how you comply with the experience requirements. #J-18808-Ljbffr
-
Senior/Principal Medical Writer
3 giorni fa
Lazio, Italia Trilogy Writing and Consulting A tempo pienoTrilogy Writing & Consulting, An Indegene Company, is currently looking to hire Senior/Principal Medical Writers (m/w/d) to support our growing company in producing high-quality regulatory documentation for the international pharmaceutical industry. At Trilogy, you will be part of a team that provides a service that goes beyond just writing. Our writers are...
-
Senior/Principal Medical Writer
21 ore fa
Lazio, Italia Trilogy Writing And Consulting A tempo pienoTrilogy Writing & Consulting, An Indegene Company, is currently looking to hire Senior/Principal Medical Writers (m/w/d) to support our growing company in producing high-quality regulatory documentation for the international pharmaceutical industry. At Trilogy, you will be part of a team that provides a service that goes beyond just writing. Our writers are...
-
Lazio, Italia Syneos Health A tempo pienoDescriptionPrincipal Medical WriterSyneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the customer and the patient to the center of...
-
Lazio, Italia Syneos Health A tempo pienoDescription Principal Medical Writer Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success.We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the customer and the patient to the center...
-
Lazio, Italia Tn Italy A tempo pienocol-wideJob Description:DescriptionPrincipal Medical WriterSyneos Health® is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the customer and...
-
Principal Technical Sourcing Engineer
1 mese fa
Lazio, Italia Mozarc Medical A tempo pieno41037 Mirandola, Province of Modena, Italy Req #198 Tuesday, July 23, 2024 About Mozarc Medical At Mozarc Medical, our vision is to reimagine the future of holistic kidney health technology.Established in 2023 out of equal investments from DaVita, a leading provider of kidney care services, and Medtronic, one of the world's largest medical device companies,...
-
Senior Medical Writing Consultant
5 mesi 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...
-
Senior Wordpress Content Writer
1 settimana fa
Lazio, Italia Hostinger A tempo pienoBecome part of the world's fastest-growing web hosting company! Join Hostinger, where we build world-class solutions for anyone to easily succeed online. Our team of 900 high-spirited professionals is behind the success of 3 million clients across 150 countries, helping them bring their online stores, blogs, and portfolios to life. We're looking for a...
-
Senior Medical Writing Consultant
1 mese 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...
-
Senior Medical Writing Consultant
3 settimane 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...
-
Senior Medical Writing Consultant
3 settimane 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...
-
Senior Medical Writing Consultant
4 ore 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...
-
Senior Medical Writing Consultant
4 settimane 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...
-
Manager, Oncology Regulatory Medical Writing
2 settimane fa
Lazio, Italia Johnson & Johnson A tempo pienoDescriptionManager, Oncology Regulatory Medical Writing (1 of 3)At Johnson & Johnson Innovative Medicine, what matters most is helping people live full and healthy lives. We focus on treating, curing, and preventing some of the most devastating and complex diseases of our time.Johnson & Johnson Innovative Medicine discovers and develops innovative medical...
-
Beauty Advisor Senior
1 mese fa
Lazio, Italia Randstad Medical A tempo pienoRandstad Medical, divisione specializzata nella ricerca e selezione di professionisti in ambito sanitario e socio assistenziale, ricerca per grande centro di medicina estetica: BEAUTY ADVISOR SENIOR.La risorsa sarà assunta con contratto full time a tempo indeterminato, con RAL commisurata all'esperienza e possibilità di crescita...
-
Senior Medical Science Liaison
1 mese fa
Lazio, Italia Eversana Company A tempo pienoSenior Medical Science Liaison (Rare Disease / Oncology) - Italy Full-time Department: Clinical & Medical At EVERSANA, we are proud to be certified as a Great Place to Work across the globe.We're fueled by our vision to create a healthier world.Our global team of more than 7,000 employees is committed to creating and delivering next-generation...
-
Senior Medical Science Liaison
1 mese fa
Lazio, Italia Eversana Company A tempo pienoSenior Medical Science Liaison (Rare Disease / Oncology) - Italy Full-timeDepartment: Clinical & MedicalAt EVERSANA, we are proud to be certified as a Great Place to Work across the globe. We're fueled by our vision to create a healthier world. Our global team of more than 7,000 employees is committed to creating and delivering next-generation...
-
Medical Marketing Lead
1 mese fa
Lazio, Italia Perrigo A tempo pienoDescription Overview Are you naturally curious by nature? Are you proactive and passionate about Medical Marketing? We are hiring an experienced Global Marketing Manager to work on a key strategic global category in one of our European Head Offices. Scope of the Role In this role, you will: Be the medical marketing lead, coordinating and influencing the...
-
Medical Marketing Lead
1 mese fa
Lazio, Italia Perrigo A tempo pienoDescription Overview Are you naturally curious by nature?Are you proactive and passionate about Medical Marketing?We are hiring an experienced Global Marketing Manager to work on a key strategic global category in one of our European Head Offices.Scope of the Role In this role, you will: Be the medical marketing lead, coordinating and influencing the...
-
Site Medical Director
4 mesi fa
Lazio, Italia Adecco Usa A tempo pienoOur organization is seeking a site medical director or senior psychiatrist to assist patients in a unique setting.More detail provided upon applying.Great pay and benefits!Pay Details: $230,000.00 to $300,000.00 per year Equal Opportunity Employer/Veterans/DisabledTo read our Candidate Privacy Information Statement, which explains how we will use your...
