This is a maternity leave contract.

The Medical Writer will be responsible for developing scientific, medical, and pharmaceutical content for various scientific and therapeutic areas.

Responsibilities

• Conducts scientific literature searches and reviews
• Participates in the development, critical review, and editing of clinical study documents including, but not limited to, study protocols, study reports, investigator's brochures, subject consent forms, integrated safety and efficacy summaries, abstracts and posters for presentation at scientific conferences and manuscripts for submission to medical journals
• Ensures adherence of document content and style to appropriate regulatory (e.g. ICH-E3 guidelines) / conference / journal / client guidelines and complies with departmental SOPs and style guidelines
• Produces high-quality content quickly and efficiently to meet deadlines
• Conducts quality control (QC) reviews of essential study documents and other documentation
• Practices good internal and external customer service
• May assist with basic statistical analyses required for medical writing deliverables, as required
• May generate new research questions and concepts to be presented to clients
• Communicates with industry and academic investigators involved in clinical studies, as well as clients and study sponsors for medical writing projects.
• Mentor and train more junior medical writing staff

Education

• Degree in healthcare, life science or related field; BSc, MSc, PhD or MD.
• Minimum 3 years’ experience in medical and/or scientific writing
• Prior pharmaceutical, biotechnology, contract research company experience

Requirements

• CRO and Life Science Industry
• Clinical research methodology
• Styles of writing for various scientific and regulatory documents
• Statistical concepts and methodology. Ability to conduct basic statistical analyses would be an asset
• Patient centric outcomes
• Survey methods
• Writing of clinical research material: protocols, reports, abstracts, manuscripts posters and presentations
• Basic knowledge of global regulations and guidelines (FDA, ICH) on drug development process and on production and publishing of essential study documents would be an asset
• Assume multiple and concurrent tasks and responsibilities with enthusiasm and deliver high-quality work while paying attention to details
• Ability to work with different project teams and adapt to a diverse portfolio of therapeutic areas
• Read, critically analyze and interpret scientific and medical journals
• Maintain and exhibit discretion at all times when handling confidential information
• Make independent decisions and use good judgment
• Plan and carry through to completion assigned tasks
• Communicate effectively orally and in writing to scientific and non-scientific groups
• Establish and maintain cooperative and effective working relations with fellow colleagues and employees
• Demonstrate integrity, respect, professionalism, commitment, accountability

Under the direction of the Director of Clinical Operations and the input of the Senior Project Manager as required, leads the project team and is responsible for coordinating project timelines and objectives related to the clinical study. Assures the management of clinical trial from initiation to closing performing project management tasks, providing support, resolving problems and organizing the team and associated tasks to meet study timelines.

Main Responsibilities:

• Ensures adherence to QA processes
• Participates in the quality control processes
• Monitors and directs the project team, suppliers, and client compliance with contract terms and commitments
• Prepares and communicates the project work plan to the project team, including project scope, schedule and budget
• Provides work assignments to project team members, and monitors/manages project production for compliance with schedules, budget and quality objectives
• Monitors suppliers’ progress and performance, and reviews suppliers’ invoices
• Maintains and monitors project financial information and manages project costs within budget constraints
• Schedules and coordinates project meetings with the project team, regulatory agencies, the client, and others involved with the projects
• Participates in the revision of the study protocol
• Creates / reviews Finalize study related documents
• Issues progress reports on the clinical trial activities
• Participates in the site recruitment and training of Sites
• Prepares / submits Ethic Committee packages
• Prepares / submits documents to Regulatory Agencies
• Plans / prepares / presents at Investigators’ meeting
• Requests preparation of study software and provides relevant details to IT
• Requests the development of the Randomization Schedule from data analysis
• Requests the completion of data analysis as per study and client requirements
• Coordinates central and local laboratory processes
• Prepares reports for Physician / Patient Payments
• Prepares recruitment update reports to the Sponsor
• Oversees the data clarifications process
• Maintains contact with sponsor and site representatives
• Conducts safety review and report Serious Adverse Events (SAEs)
• Assists in the preparation of data analysis
• Assists in preparation of interim and final reports
• Assists in the writing/reviewing of manuscripts
• Prepares/reviews abstracts, posters, presentations, CD-ROMs, etc
• Participates in the development and review process of SOPs

Education and experience

• M.Sc. in Life Sciences or equivalent B.Sc. with relevant work experience in clinical research
• 2 years’ experience as a Project Manager
• Experience managing international studies is an asset Requirements
• Maintain and exhibit discretion at all times when handling confidential information
• Lead a multi-disciplinary project team
• Make independent decisions and use good judgment
• Plan, organize, and prioritize tasks efficiently
• Communicate effectively orally and in writing
• Assume multiple and concurrent tasks and responsibilities
• Establish and maintain cooperative and effective working relations with fellow colleagues
• Communicate effectively with clients and site representatives
• Demonstrate integrity, respect, professionalism, commitment, accountability
• The CRO & Life Sciences industries
• Project management principles
• Quality assurance principles
• MS Office
• Good Clinical Practices
• Good Documentation Practices
• 21 CFR Part 11 for Handling of Electronic Records

Works under the general supervision of the Scientific Affairs / Data Analysis Department hierarchy as required, performing tasks related to the conduct of clinical trials. Under general direction and guidance from the Senior Scientific Director, participates in the design of clinical trials and research projects, the analysis and interpretation of data, and the dissemination of results.

Responsibilities

• Participates in the investigational process from initiation to closing, as required
• Ensures adherence to Quality Assurance processes
• Participates in the development and review process of SOPs for the Scientific Affairs / Data Analysis Department
• Creates / Reviews study related documents. These include, but are not limited to:
• Study Protocol
• Statistical Analysis Plan
• Data Analysis reports
• Posters
• Presentations
• Clinical reports
• Abstracts
• Regulatory submissions
• Ethics submissions
• Presentations
• Manuscripts
• Progress reports
• Recruitment update reports
• CDs
• Plans / Prepares for and presents at Investigator’s meeting
• Assists in sample size calculations and the development of study specific randomization schedules
• Performs statistical analyses to characterize and improve different aspects of a study
• Transfers study related data from client database and/or in-house developed database into
• statistical analysis software
• Reorganize and prepare data, assure quality of data prior to conducting data analysis
• Reviews study materials, including case report forms, to:
• Determine data accuracy and completeness
• Detect study protocol deviations and data discrepancies
• Conduct safety reviews
• Offers support on a variety of statistical issues
• Communicates with the sponsor and/or site representatives
• Reports, reviews and codes adverse events (including serious and non-serious) Organizes workflow in compliance with timelines
• Participates in department and project audits

Education

• A minimum of a Bachelor’s degree or college diploma in Science or Life Sciences.
• Relevant work experience with statistical analyses and/or clinical research