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Senior Medical Writer
2 months ago
We are seeking to appoint a Senior Medical Writer to join our dedicated team.
FOCUS OF THE JOB:
- A Senior level regulatory Medical Writer with the attention to detail, interpersonal skills and scientific knowledge needed to collaborate effectively with MAC colleagues and Sponsors.
- Ability to research, author, review, edit and perform quality control on clinical regulatory documents such as Protocols, Patient Information Sheets, Informed Consent Forms, Investigator Brochures (IBs), Clinical Study Reports (CSRs), Lay Summaries, Abstracts and Manuscripts relating to the conduct and reporting of clinical trials in Phase 1-3.
- Excellent written and spoken English and the confidence to drive process improvements, best working practices and Standard Operating Procedures (SOPs) to deliver to the highest quality standards.
KEY SKILLS, KNOWLEDGE AND QUALIFICATIONS REQUIRED:
- Educated to Bachelor’s degree level or higher, preferably in life sciences, medicine, pharmacy or a related discipline.
- Experience of clinical study design and optimisation, knowledge of drug development and experience in regulatory writing for a clinical research organisation, industry and pharmaceutical company.
- Knowledge of or experience in the conduct of clinical trials.
- Proven expertise in science and/or healthcare and knowledge 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.
- Experience with 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 and lead in a collaborative team environment and support colleagues to achieve high quality outcomes.
- Well organised, flexible and able to plan multiple projects 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 and the ability to coach others in editorial review.
- Ability to manage and prioritise multiple projects simultaneously and to supervise the work of more junior writers.
- Computer literate –Word, PowerPoint, Excel, Teams, Sharepoint, Adobe.
Desirable skills/experience
- MSc or PhD in life sciences, medicine, pharmacy or a related discipline.
- Previous experience of Medical Writing in a clinical research environment and knowledge of the relevant regulatory requirements. Preferably, a minimum of 3 years in a Medical Writing role within a pharmaceutical company, Contract Research Organisation.
- Previous experience working as lead Medical Writer on Protocol, IB, CSR and/or regulatory dossiers across Phases 1-3 and in various therapy areas including mental health and psychedelic drugs.
- Experience in the technical aspects of document formatting and preparation, the use of Adobe Acrobat for signatures and manipulation of PDFs, the use of a reference manager and collaborative authoring tools would be advantageous.
- Experience working to the rigorous global regulatory standards required for drug development and the clinical trial process including experience interacting with colleagues and Subject Matter Experts across Biometrics, Clinical Operations and Sponsor organisations.
RESPONSIBILITIES:
- Serve as Senior Medical Writer for allocated projects, confident to lead 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, including but not limited to: investigator brochures, study protocols, informed consent forms, interim and final clinical study reports.
- Provide mentoring and guidance to members of the Medical Writing team and perform expert document review and approval.
- Manage document review cycles, comment resolution and incorporation to ensure inclusion of the 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 and, where necessary lead data-focussed discussions, collaborating with the project manager and project team to ensure deliverables are effectively planned, coordinated, and delivered.
- Work with the project team to proactively identify potential risks and suggest mitigation and contingency plans.
- Confident to drive medical writing discussions and lead key meetings with subject matter experts to deliver regulatory documents 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.
- Mentor and support other members of the project team as needed.
- Provide training and guidance to less experienced Medical Writers.
- Write, review and update departmental SOPs and associated forms and templates.
BENEFITS:
- Competitive salary in keeping with pharmaceutical industry standards that will reflect experience
- Health Insurance
- 25 days annual leave (increasing in increments to 30 days after 6 years' service)
- Your birthday off work
MAC is an expanding full-service global CRO with an established network of 10 clinical trial sites in the UK. Our mission is to serve with honesty and integrity to make an outstanding contribution to human health. We have been in the Clinical Trials business for more than twenty years and are a relatively small organisation meaning we all know each other and are well placed to work collaboratively to provide a bespoke, agile service to our clients. In the light of our continuing success, we are growing our team of exceptional talent. If you have the skills and enthusiasm we seek, and would like to develop your career with us, we would love to hear from you.
MAC Clinical Research invites applications from highly motivated candidates, with a desire to fulfil their full potential. You will be working with an organisation that sees you as an investment and is keen for you to achieve your career aspirations.
This role is home based and therefore we require you to have a suitable set up at home that allows you to work comfortably. This includes an appropriate desk and chair (excl. IT equipment which we will provide), please confirm you are able to do this before proceeding with your application.
Please email should you require any special arrangements or reasonable adjustments to be made throughout this selection process. This will enable us to accommodate your request as necessary.
