Regulatory Medical Writer
6 days ago
We are seeking a highly skilled Medical Writer to join our team at MAC Clinical Research. As a Medical Writer, you will play a critical role in the development of clinical documents for submission to regulatory authorities.
Key Responsibilities- Serve as Medical Writer for allocated projects, confident to represent the Medical Writing function in meetings with internal colleagues and sponsors and drive document delivery.
- Take the lead in gathering, reviewing, analysing, and evaluating pertinent resources to prepare, author, develop, and finalise clinical documents for submission to regulatory authorities.
- Manage document review cycles, comment resolution and incorporation to ensure inclusion of all relevant input.
- Publish PDF versions of final clinical documents to approved standards.
- Quality Control - Provide peer review and quality control of draft and final documents against approved sources to ensure suitability for external distribution.
- Support the preparation of, or act as the Medical Writing lead in, client meetings and teleconferences.
- Participate in data-focussed discussions, meeting frequently with the project manager and project team to ensure deliverables are effectively planned and coordinated.
- Work with the project team to proactively identify potential risks and put in place mitigation and contingency plans.
- Have the confidence to drive medical writing discussions and lead key meetings with subject matter experts to achieve project deliverables on time and to high quality.
- Review and provide input into project plans and documentation such as the Clinical Trial Design, Data Management Plan, Statistical Analysis Plan, Tables Figures and Listings.
- Support the participation of other members of the project team into Medical Writing deliverables.
- Provide training and guidance to Associate Medical Writers.
- Provide input to the writing, reviewing and updating of departmental SOPs and associated forms and templates.
- Educated to at least Bachelor's degree level, preferably in life sciences, medicine, pharmacy or a related discipline.
- Knowledge of clinical study design, drug development and the relationship between a clinical research organisation, industry and pharmaceutical clients.
- Knowledge of or experience in the conduct of clinical trials.
- Passion for science and healthcare and an understanding of risk benefit.
- Ability to read, analyse, and interpret complex scientific and clinical information and write a clear, succinct summary targeted at the relevant audience.
- Ability to understand mathematical concepts such as probability and statistical inference.
- Ability to write articles for peer-reviewed publications that conform to the prescribed journal style and format.
- Ability to work in a collaborative team environment and support colleagues to achieve high quality outcomes.
- Well organised, flexible and able to plan and work effectively to tight deadlines.
- Excellent interpersonal skills including written English and clear oral communication.
- A keen eye for detail across scientific content, consistency and editorial standards.
- Ability to manage and prioritise multiple projects simultaneously.
- Computer literate –Word, PowerPoint, Excel, Teams, Sharepoint, Adobe.
- PhD in life sciences, medicine, pharmacy or a related discipline.
- Must have previous experience of Medical Writing in a clinical research environment and knowledge of effective Medical Writing Practices. Preferably, a minimum of 18 months in a Medical Writing role, within a pharmaceutical company, Contract Research Organisation, or Medical Communications Agency.
- Previous experience working as a Medical Writer on Protocol and CSR projects across Phases 1-3 and various therapy areas including mental health and psychedelic drugs.
- Experience in the technical aspects of document formatting, Adobe Acrobat for signatures and manipulation of PDFs, use of reference manager and collaborative authoring tools would be advantageous.
- Knowledge of the regulatory framework that surrounds drug development and the clinical trial process including the interaction between Medical Writing, Biometrics and Clinical Operations.
- Competitive salary in keeping with pharmaceutical industry standards that will reflect experience.
- Health Insurance.
- Free onsite parking.
- 25 days annual leave (increasing in increments to 30 days after 6 years' service).
- Your birthday off work.
-
Medical Writer
4 days ago
London, Greater London, United Kingdom Costello Medical Full timeAbout Costello Medical Costello Medical is a leading provider of innovative medical solutions, dedicated to improving patient care and advancing healthcare research. We are committed to fostering a collaborative and dynamic work environment where talented individuals can contribute their expertise and make a meaningful impact. The Role: Medical Writer -...
-
Medical Writer
2 weeks ago
London, Greater London, United Kingdom Costello Medical Full timeAbout Costello Medical Costello Medical is a leading provider of innovative medical solutions, dedicated to improving patient care and advancing healthcare research. We are committed to fostering a collaborative and dynamic work environment where talented individuals can contribute their expertise and make a meaningful impact. The Role: Medical Writer -...
-
Medical Writer
4 days ago
London, Greater London, United Kingdom MAC Clinical Research Full timeJob SummaryWe are seeking a highly skilled and experienced Clinical Regulatory Writer to join our team at MAC Clinical Research. As a key member of our team, you will be responsible for creating high-quality clinical documents for submission to regulatory authorities.Key ResponsibilitiesDevelop and finalize clinical documents, including investigator...
-
Medical Writer
5 days ago
London, Greater London, United Kingdom MAC Clinical Research Full timeJob SummaryWe are seeking a highly skilled and experienced Clinical Regulatory Writer to join our team at MAC Clinical Research. As a key member of our team, you will be responsible for creating high-quality clinical documents for submission to regulatory authorities.Key ResponsibilitiesDevelop and finalize clinical documents, including investigator...
-
Medical Writer
6 days ago
London, Greater London, United Kingdom MAC Clinical Research Full timeAbout the RoleWe are seeking a highly skilled and experienced Clinical Regulatory Writer to join our team at MAC Clinical Research.Key Responsibilities:Serve as a Medical Writer for allocated projects, confident to represent the Medical Writing function in meetings with internal colleagues and Sponsors and drive document delivery.Take the lead in gathering,...
-
Medical Writer
4 days ago
London, Greater London, United Kingdom MAC Clinical Research Full timeAbout the RoleWe are seeking a highly skilled and experienced Clinical Regulatory Writer to join our team at MAC Clinical Research.Key Responsibilities:Serve as a Medical Writer for allocated projects, confident to represent the Medical Writing function in meetings with internal colleagues and Sponsors and drive document delivery.Take the lead in gathering,...
-
Clinical & Regulatory Medical Writer
6 days ago
London, Greater London, United Kingdom McCann Health London | An IPG Health Company Full timeAbout the RoleWe are seeking a skilled Medical Content Specialist to join our team at McCann Health London | An IPG Health Company. As a Medical Content Specialist, you will be responsible for creating high-quality promotional healthcare content that adheres to regulatory requirements.Key ResponsibilitiesDevelop and implement communication strategies,...
-
Medical Writer
6 days ago
London, Greater London, United Kingdom MAC Clinical Research Full timeAbout the RoleWe are seeking a highly skilled and experienced Medical Writer to join our team at MAC Clinical Research. As a Medical Writer, you will play a crucial role in the development and delivery of high-quality clinical documents for our clients.Key ResponsibilitiesDevelop and author clinical documents, including protocols, patient information sheets,...
-
Senior Medical Writer
8 hours ago
London, Greater London, United Kingdom MAC Clinical Research Full timeJob DescriptionJob Title: Senior Medical Writer - Clinical ResearchJob Summary:We are seeking a highly skilled and experienced Senior Medical Writer to join our team at MAC Clinical Research. As a Senior Medical Writer, you will be responsible for creating high-quality clinical study documents, including protocols, informed consent forms, and clinical study...
-
Senior Medical Writer
11 hours ago
London, Greater London, United Kingdom MAC Clinical Research Full timeJob DescriptionJob Title: Senior Medical Writer - Clinical ResearchJob Summary:We are seeking a highly skilled and experienced Senior Medical Writer to join our team at MAC Clinical Research. As a Senior Medical Writer, you will be responsible for creating high-quality clinical study documents, including protocols, informed consent forms, and clinical study...
-
Senior Medical Writer
4 days ago
London, Greater London, United Kingdom MAC Clinical Research Full timeJob DescriptionJob Title: Senior Medical Writer - Clinical ResearchJob Summary:We are seeking a highly skilled and experienced Senior Medical Writer to join our team at MAC Clinical Research. As a Senior Medical Writer, you will be responsible for creating high-quality clinical study documents, including protocols, informed consent forms, and clinical study...
-
Senior Medical Writer
4 days ago
London, Greater London, United Kingdom MAC Clinical Research Full timeJob DescriptionJob Title: Senior Medical Writer - Clinical ResearchJob Summary:We are seeking a highly skilled and experienced Senior Medical Writer to join our team at MAC Clinical Research. As a Senior Medical Writer, you will be responsible for creating high-quality clinical study documents, including protocols, informed consent forms, and clinical study...
-
Principal Medical Communications Specialist
7 days ago
London, Greater London, United Kingdom Medical Talent Full timeJob Opportunity at Medical TalentAbout the RoleWe are seeking a highly skilled and experienced Senior Medical Copywriter to join our team at Medical Talent. As a key member of our healthcare advertising agency, you will be responsible for leading the development of creative promotional materials for a wide range of therapy areas, including oncology, rare...
-
Principal Medical Communications Specialist
4 days ago
London, Greater London, United Kingdom Medical Talent Full timeJob Opportunity at Medical TalentAbout the RoleWe are seeking a highly skilled and experienced Senior Medical Copywriter to join our team at Medical Talent. As a key member of our healthcare advertising agency, you will be responsible for leading the development of creative promotional materials for a wide range of therapy areas, including oncology, rare...
-
Lead Medical Writer
6 days ago
London, Greater London, United Kingdom MEDIA CONTACTS Full timeA leading healthcare communications agency, Media Contacts, is seeking a highly experienced and ambitious Principal Medical Writer to join their team. The agency has a strong reputation for delivering high-quality, scientifically accurate content across a range of channels and audiences.This is an exciting opportunity for a seasoned medical writer to take on...
-
Lead Medical Writer
4 days ago
London, Greater London, United Kingdom MEDIA CONTACTS Full timeA leading healthcare communications agency, Media Contacts, is seeking a highly experienced and ambitious Principal Medical Writer to join their team. The agency has a strong reputation for delivering high-quality, scientifically accurate content across a range of channels and audiences.This is an exciting opportunity for a seasoned medical writer to take on...
-
Senior Medical Writer
4 days ago
London, Greater London, United Kingdom MAC Clinical Research Full timeAbout the RoleWe are seeking a highly skilled and experienced Senior Medical Writer to join our team at MAC Clinical Research. As a Senior Medical Writer, you will play a critical role in the development and delivery of high-quality clinical study documents, including protocols, investigator brochures, informed consent forms, and clinical study reports.Key...
-
Senior Medical Writer
3 days ago
London, Greater London, United Kingdom MAC Clinical Research Full timeAbout the RoleWe are seeking a highly skilled and experienced Senior Medical Writer to join our team at MAC Clinical Research. As a Senior Medical Writer, you will play a critical role in the development and delivery of high-quality clinical study documents, including protocols, investigator brochures, informed consent forms, and clinical study reports.Key...
-
Senior Medical Writer
13 hours ago
London, Greater London, United Kingdom MAC Clinical Research Full timeJob DescriptionJob Title: Senior Medical WriterJob Summary:We are seeking a highly skilled and experienced Senior Medical Writer to join our team at MAC Clinical Research. As a Senior Medical Writer, you will be responsible for creating high-quality clinical documents, including protocols, informed consent forms, and clinical study reports, for submission to...
-
Senior Medical Writer
10 hours ago
London, Greater London, United Kingdom MAC Clinical Research Full timeJob DescriptionJob Title: Senior Medical WriterJob Summary:We are seeking a highly skilled and experienced Senior Medical Writer to join our team at MAC Clinical Research. As a Senior Medical Writer, you will be responsible for creating high-quality clinical documents, including protocols, informed consent forms, and clinical study reports, for submission to...
