Senior Medical Writer

We are seeking to appoint a Senior Medical Writer to join our dedicated Medical Writing (Biometrics) team.

MAC Clinical Research has built a network of fully owned sites over the last 30+ years, we 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. 

FOCUS OF THE JOB:   

• A Senior level Regulatory Writer with the attention to detail, scientific knowledge and interpersonal skills needed to collaborate effectively with MAC colleagues and Sponsors for the delivery of quality regulatory documents.
• To research, author, review, edit and perform quality control on clinical regulatory documents such as Protocols, Patient Information Sheets, Informed Consent Forms, Investigator Brochures, Clinical Study Reports, Lay Summaries, Abstracts and Manuscripts for the conduct and reporting of clinical trials in Phases 1-3.
• Confidently contribute to process improvements, best working practices and Standard Operating Procedures (SOPs) and deliver to the highest quality standards. 

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.

KEY SKILLS, KNOWLEDGE AND QUALIFICATIONS REQUIRED:  

• Educated to at least Bachelor’s degree level in life sciences, medicine, pharmacy or a related discipline. 
• At least 3 years’ experience as a Regulatory Medical Writer within a pharmaceutical company, Contract Research Organisation, or Medical Communications Agency leading on Protocol, Investigator Brochure (IB) and Clinical Study Report (CSR) projects across Phases 1-3.
• Experience across a variety of therapeutic areas including neuroscience and mental health.
• Knowledge of clinical trials, clinical study design, drug development and the relationship between a CRO, industry and pharmaceutical clients. 
• Passion for science and healthcare and an understanding of risk benefit and pharmacovigilance activities. 
• Confidence to critically review clinical data and provide feedback on table shells and tables, figures and listings (TFLs).
• Ability to analyse and interpret complex scientific and clinical information and write clearly and succinctly to regulatory guidelines. 
• Ability to interpret and convey pharmacokinetic and pharmacodynamic data.
• Understanding of mathematical concepts such as probability and statistical inference. 
• Ability to write articles for peer-reviewed publications that conform to a prescribed journal style and format. 
• Ability to work under pressure 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, ensuring consistency and adherence to editorial standards. 
• Ability to manage and prioritise multiple projects simultaneously. 
• Computer literate – Word, PowerPoint, Excel, Teams, Sharepoint, Adobe.

Desirable skills/experience 

• MSc. or PhD in life sciences, medicine, pharmacy or a related discipline. 
• Knowledge of effective Medical Writing Practices. 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.
• Experience in the use of a reference manager such as Endnote or similar.
• Experience in the use of collaborative authoring tools such as PleaseReview.
• Knowledge of the regulatory framework that surrounds drug development and the clinical trial process including the interaction between Medical Writing, Biometrics and Clinical Operations. 

RESPONSIBILITIES:  

• Serve as Senior Medical Writer able to lead on allocated projects, confident to chair meetings with internal colleagues and Sponsors and drive document delivery. 
• Able to lead in the gathering, reviewing, analysing, and evaluating of pertinent resources.
• Able to prepare, author, develop, and finalise clinical documents for submission to regulatory authorities, including but not limited to: IBs, study protocols, informed consent forms, interim and final clinical study reports. 
• Provide mentoring and guidance to members of the Medical Writing team.
• 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-focused 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. 

• Health Insurance
• Free onsite parking
• Cycle to work scheme
• Eye care vouchers
• 25 days annual leave (increasing in increments to 30 days after 6 years' service)
• Your birthday off work

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.

Please email [email protected] 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.