- MAC - FULL TIME
SENIOR MEDICAL WRITER
Closing date for applications: 27 March 2023
MAC Clinical Research manages clinical trials for the pharmaceutical industry, and we are seeking to appoint a Senior Medical Writer to join our Medical Writing team at our expanding Contract Research Organisation. We are happy to be flexible with regards to location in the UK, so any of our clinical site locations may be considered or could be fully home based.
The focus of this role is to represent the Medical Writing Department in researching, creating, reviewing and editing documents associated with clinical research in order to support MAC Clinical Research and its customers. Responsibilities will also include: acting as the primary client contact for Medical Writing projects, working with other MAC departments and clients to set and meet internal/external deliverable timelines, project leadership, and training/support/line management of junior Medical Writing staff.
KEY RESPONSIBILITIES:
Write/compile, peer review and edit medical writing deliverables, that includes, but is not limited to:
Clinical Study Protocols and Clinical Protocol Amendments
Clinical Study Reports
Investigator Brochures
Journals and Manuscripts
Reviewing Statistical Analysis Plans and table/figure/listing specifications for appropriate content, grammar, format, and consistency.
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, and participate in, client meetings and teleconferences.
Provide support to the Medical Writing department assigned to individual projects.
Support the Medical Writing team to ensure delivery of high-quality deliverables, on time and in-line with customer expectations to achieve a high level of customer satisfaction.
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.
Review the project team’s output regularly to ensure the highest quality deliverables.
Ensure that all relevant protocols, project plans, SOP’s and regulatory requirements are adhered to.
Communicate risks and issues effectively to the project team and provide regular updates on Medical Writing deliverables to the project team.
Support the input of other members of the project team into Medical Writing deliverables.
Develop and drive best working practices and process improvement. Input in writing, reviewing and updated departmental SOPs and associated forms and templates.
Attend and provide input to internal, client or regulatory audits or inspections.
KEY REQUIREMENTS:
Educated to at least Bachelor’s degree level, preferably in life sciences, medicine, pharmacy or a related discipline.
3+ years of prior Medical Writing experience within the CRO/Pharmaceutical/Biotech industry or within a drug-development environment, working on Protocol and CSR projects across all clinical trial phases and a variety of therapeutic areas.
Passion for science and healthcare.
Excellent computer skills including knowledge of Adobe, Internet software, Spreadsheet software, Word Processing software, Graphics software (e.g., PowerPoint or Prism), Bibliographic software (e.g., EndNote) and any other applicable software.
Experience of reading, analysing, and interpreting common scientific and technical journals.
Experience of interpreting and presenting clinical data and other complex information.
Excellent oral and written communicative skills. Fluent in oral and written English.
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.
Excellent time management to organise and prioritise workload and those of any Medical Writing Department team members under their supervision (if applicable).
Ability to lead by example on process development, departmental and project objectives, and overall business strategy and initiatives.
Ability to work in a collaborative team environment.
Able to proactively identify risks and issues and be able to devise mitigation and contingency plans and solve problems as they arise. Encourage and support team members to apply the same approach to seek solutions.
Knowledge of drug development process including the relationship between the CRO industry and pharmaceutical companies.
Knowledge of the regulatory framework that surrounds drug development and the clinical trial process.
Knowledge of clinical trial process; including the interaction between the Medical Writing team with the wider Biometrics team and Clinical Operations.
DESIRED SKILLS/EXPRIENCE
PhD in life sciences, medicine, pharmacy or a related discipline.
5+ years of prior Medical Writing experience within the CRO/Pharmaceutical/Biotech industry or within a drug-development environment, working on Protocol and CSR projects across all clinical trial phases and a variety of therapeutic areas.
An awareness of clinical database applications, which may include (but not limited to) Medrio, Oracle Clinical, Medidata, SAS.
Experience of authoring common technical document (CTD) authoring and submissions would be beneficial.
BENEFITS:
Competitive salary in keeping with pharmaceutical industry standards and will reflect experience
Free onsite parking
25 days annual leave plus bank holidays (increasing in increments to 30 days after 6 years long service)
Your birthday off work
Regular hours (including Christmas Day, Boxing Day and New Year’s Day off)
MAC Clinical Research invites applications from highly motivated candidates, with a desire to achieve their full potential. You will be working within an organisation that sees you as an investment and is keen for you to achieve your career aspirations.
Salary: Competitive + Negotiable £ Apply Now
