Freelance Medical Writer
1 month ago
Our client is a fast-growing biotech company. At only six years old they already have a development portfolio of nine products. Including a partnered product that is in commercial production and that has seen more than 3 billion doses administered worldwide and an IPO behind them.
They discover and develop immunotherapeutic products and vaccines for the treatment and prevention of infectious diseases and cancer.
They conduct research globally and have ambitious plans in the UK and US, where they will continue to grow their teams over the coming months and years.
The Role
They are looking for Freelance Regulatory Medical Writer contractors - especially any with Orphan Drug Application, Breakthrough/ Fast Track Applications experience. Ideally clinical, regs, and CMC experience.
You will provide medical writing expertise for multiple products and projects. This will include interfacing cross functionally to ensure accurate and timely completion and delivery of information and review of scientific publications or clinical regulatory submissions. Serving as the scientific writing expert for the company, key stakeholders will be medical, clinical, manufacturing, programme management, research, immunology, regulatory affairs and QA.
As part of the job you will write, or have input into, documents for submission to regulatory authorities, including briefing documents, clinical development plans, previous human experience summaries, human pharmacology summaries, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical documents (CTDs) clinical/non-clinical overviews and summaries, safety update/aggregate reports and integrated summaries of safety and efficacy. You will need to coordinate quality control reviews of documents and maintain audit trails of changes; provide input on data analysis planning and interpretation.
Experience & Qualifications
You will have extensive medical writing experience within the clinical research field together with a demonstrated understanding of the drug development process, and applicable regulatory guidelines.
Experience with writing a variety of documents (Clinical Study Reports, Investigator Brochures, protocols/amendments, safety narratives, Developmental Safety Update Reports, scientific publications, briefing books.
Experience in early phase (I-II) studies
Excellent working knowledge of ICH GCP and current clinical trial legislation and current medical/ scientific/ manuscript writing guidance.
-
Freelance Medical Writer
2 months ago
UK, UK, United Kingdom Meet Full timeA global independent medical communications agency is looking for a Freelance Senior Medical Writer to join their medical education team. An initial end-of-year contract, working outside of IR35, and paying competitively.The role:As a Freelance Medical Writer you are valued for your scientific input. You will be involved in a wide range of medical...
-
Freelance Regulatory Writer
3 days ago
, UK,, UK, United Kingdom Barrington James Full timeLooking for a new Regulatory Writing contract? Excited to announce that Barrington James are working with a Consultancy who are looking to grow their team. They are looking for an experienced Freelance Regulatory Writer, based in Europe! The details of the contract: Flexible FTE 12 month contract Remote Outside IR35 You will be responsible for: ...
-
UX Writer
2 weeks ago
UK, UK, United Kingdom Zebra People Part timeFreelance UX Writer – £450/day (outside IR35)Are you a seasoned UX writer with a knack for creating style guides and a wealth of experience in crafting user-centric content? We’re working with a well-respected design studio that's looking for someone like you!What We Need:Strong experience in UX writing, with a particular focus on developing style...
-
Senior Medical Writer
3 weeks ago
UK, UK, United Kingdom Life Sciences Recruitment Full timeAs a Senior/Principal Medical Writer, You WillPrepare 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...
-
Expert Scientific Writer
2 months ago
UK, UK, United Kingdom SRG Full timeExpert Scientific Writer – Medical / Pharma Contract role – 6 months, extendableRate = €450-500 per day (Ireland based) or £375-400pd (UK based)Location: UK based or Ireland based candidates only. Hybrid or Remote working. NO SPONSORSHIP provided, so You MUST hold UK citizenship OR EU/EEA citizenship or hold existing full rights to work in Ireland or...
-
Lead Medical Writer
3 weeks ago
UK, UK, United Kingdom BioTalent Full timeLead Medical Writer - United Kingdom (Remote)BioTalent are Partnered with a global medical communications agency and we are looking for a Lead Medical Writer to join the team with extensive experience in publications and ideally exposure to oncology.You will lead delivery on small-to-medium accounts, ensuring top-quality work on time and within budget, while...
-
Lead Medical Writer
2 months ago
UK, UK, United Kingdom Meet Full timePosition: Lead Medical Writer (Regulatory Focus)Location: Remote (UK, Germany, or France)As a Lead Medical Writer, you will be responsible for planning, drafting, and managing the review process for documents related to clinical studies and regulatory submissions. These documents may include key sections of marketing applications, protocols, clinical study...
-
Senior Medical Writer
3 weeks ago
UK, UK, United Kingdom CMC Affinity | An IPG Health Company Full timeSenior Medical Writers define new directions with CMC Affinity.We innovate. We inspire. We show others the way. We lead from the front with the courage and confidence that flows from our own expertise. We relish every opportunity to play a vital role in communicating the world's finest science, health and well-being. You will, too.You're an...
-
Medical Writer
1 month ago
UK, UK, United Kingdom Mortal And Strong Full timeCompany DescriptionMortal And Strong is a charity focused on using medical professional support and art to approach disease prevention and support for those facing mortality at a young age. The charity collaborates with organizations of specialist support, working across conditions, communities, and cultures. The Scars of Gold campaign is a doctor-led...
-
Freelance Copywriter
3 weeks ago
UK, UK, United Kingdom EPM Scientific Part timeEPM Scientific are currently working with a reputable Medical Communications agency, who are looking for an experienced Medical Copywriter to join our team on a flexible, part-time basis (30 hours per week) for six months.Freelance Medical Copywriter – Med Comms AgencyKey Responsibilities:Craft engaging promotional/creative and medical education...
-
Senior Medical Writer
3 weeks ago
UK, UK, United Kingdom BioTalent Full timeSenior Medical Writer - United Kingdom (remote)BioTalent are Partnered with a global medical communications agency who are looking for Senior Medical Writers to join their team with a focus on Oncology projects.We are looking for those with a strong scientific foundation, that excel in translating complex concepts into clear, engaging content. SMWs produce...
-
Senior Medical Writer
5 months ago
UK, UK, United Kingdom Cognite Full timeIn the fast-changing world in which our clients seek to deliver life-changing medicines and technology, Cognite’s dynamic and forward-thinking team drives us in our mission of bringing science to life.As an independent agency, we develop innovative communications that convey science in the most effective and engaging way possible. Cultivating partnerships...
-
Principal Medical Writer
3 weeks ago
UK, UK, United Kingdom CM Consulting Full timePrincipal Medical Writer role; PUBLICATION ACCOUNTS.We have an exclusive new Principal Medical Writer role to tell you about, working on PUBLICATION ACCOUNTS.Working on high science and strategic accounts, our client, a fully independent and very successful medium-sized agency, are looking for an experienced full-time PMW to join their growing publications...
-
Medical Writer for AI Software Company
1 month ago
UK, UK, United Kingdom TriloDocs Full timeAre you excited about AI tools used for medical writing? TriloDocs is an AI tool that generates an initial draft of a Clinical Study Report that accurately reflects the source material (protocol, statistical analysis plan, data tables and figures). The tool not only creates formatted tables and figures but also meaningful text around them, highlighting...
-
Principal Medical Writer, London
4 months ago
UK, UK, United Kingdom Langland Full timePrincipal Medical WriterWood Lane, London, W12Company DescriptionWho we areLangland, a Publicis Health company, is the only health communications agency that thinks further across Clinical Trial Experience, Medical Strategy & Education, Public Relations & Policy, and Advertising, to create unique value with visionary clients.What we believeHealth brings us...
-
Principal Medical Writer
2 weeks ago
UK, UK, United Kingdom pobl. Full timeAmbitious and experienced medical writer, specialising in market access and wanting a place where you can channel your creativity into impactful value communications?pobl. is working exclusively with a boutique market access and value communications agency to find a number of highly talented and experienced medical writers to join a growing and...
-
Senior and Principal Medical Writers
1 month ago
UK, UK, United Kingdom pobl. Full timeAmbitious medical writer, specialising in market access and wanting a place where you can channel your creativity into impactful value communications?pobl. is working exclusively with a boutique market access and value communications agency to find a number of talented medical writers to join a growing and entrepreneurial team. This agency partners with...
-
Principal/Sr Medical Writer
4 weeks ago
; Homeworking, , UK; Homeworking,, UK, United Kingdom Syneos Health Full timeDescription Senior 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...
-
Principal Medical Writer
2 months ago
; Homeworking, , UK; Homeworking,, UK, United Kingdom Syneos Health Full timeDescription 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...
-
Principal/Sr Medical Writer
3 weeks ago
; Homeworking, , UK; Homeworking,, UK, United Kingdom Syneos Health Full timeDescription 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 of everything that we...