MAC is a full-service global Contract Research Organisation (CRO). We also own a network of research sites. Our mission is to serve with honesty and integrity to make an outstanding contribution to human health.
We are seeking to appoint a Medical Writerto join our dedicated team.
FOCUS OF THE JOB:

• To research, create, review and edit documents assigned to the Medical Writing Department associated with clinical research in order to support MAC Clinical Research and its customers.
• To assist in developing best working practices and Standard Operating Procedures in delivering the portfolio of projects within the Medical Writing Department.

KEY SKILLS, KNOWLEDGE AND QUALIFICATIONS REQUIRED:
Essential skills, knowledge and qualifications

• Educated to at least Bachelor’s degree level, preferably in life sciences, medicine, pharmacy or a related discipline.
• Minimum of 2 years medical writing experience in early phase studies
• Knowledge of drug development process including the relationship between the clinical research organisation industry and pharmaceutical companies.
• Passion for science and healthcare.
• Ability to read, analyse, and interpret complex scientific and clinical information to provide a clear, succinct summary targeted at relevant audience.
• Ability to understand mathematical concepts e.g., probability and statistical inference.
• Ability to write articles for peer-reviewed publications that conform to the prescribed style and format.
• Ability to work in a collaborative team environment.
• Well organised, flexible and able to plan work effectively to tight deadlines.
• Excellent written and oral communication skills. Fluent in oral and written English.
• A keen eye for detail across scientific content and editorial standards.
• Good interpersonal skills.
• Ability to work simultaneously across multiple projects.
• Computer literate – Word, Power Point, Excel, Internet.

Desirable skills/experience

• Ph D in life sciences, medicine, pharmacy or a related discipline.
• 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 all clinical trial phases and therapeutic areas.
• Knowledge of the regulatory framework that surrounds drug development and the clinical trial process.
• Knowledge of the clinical trial process: including the interaction between the Medical Writing team with the Biometrics team and Clinical Operations.
• Experience with Adobe Acrobat.

RESPONSIBILITIES (including staff):

• Serve as the Medical Writer for allocated projects.
• Authoring clinical documents:
• Take the lead in gathering, reviewing, analysing, and evaluating pertinent resources to prepare, 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.
• Revise document drafts based on the review comments from team members or sponsors to ensure inclusion of all relevant input.
• Publish PDF versions of final clinical documents to approved standards.
• Quality Control - Provide medical editing review of draft and final documents prepared by other writers before internal or external distribution. This includes both copyediting and content review.
• Support the preparation of, or act as the Medical Writing lead in, client meetings and teleconferences.
• Participate in data-focussed project team meetings, meeting frequently with the project team to ensure that all deliverables are planned and coordinated within the project team.
• Work with the project team to proactively identify potential risks and put in place mitigation and contingency plans.
• Effectively communicate any medical writing-driven discussions to achieve project deliverables on time and to high quality.
• Generate, review and provide input into project plans and documentation e.g. Protocol, Data Management Plan, Statistical Analysis Plan, Clinical Study Report.
• Support the input of other members of the project team into Medical Writing deliverables.
• Provide training and guidance to Associate Medical Writers.
• Provide input in the writing, reviewing and updating of departmental SOPs and associated forms and templates.

BENEFITS:

• 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

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 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 maccareers@macplc.com 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.
Job Type: Full-time
Benefits:

• Company pension
• Free parking
• Health & wellbeing programme
• On-site parking
• Private medical insurance
• Referral programme
• Work from home

Schedule:

• Monday to Friday

Application question(s):

• Do you require sponsorship to work in the UK (now or in the future?)

Experience:

• medical writing in early phase studies: 2 years (required)

Work authorisation:

• United Kingdom (required)

Work Location: Remote