Medical Writer - Maternity Cover

A Career with Purpose Bionical Emas is a global Early Access Programs (EAP) and Clinical Trial Supply (CTS) group bringing life-changing medicines to patients around the world. Their range of services and capabilities benefit many of the world's leading pharma and biotech companies. About The Role We are looking for a Senior Medical Writer for a maternity cover who will be responsible for leading and managing the medical writing activities across the company, including researching, creating, and editing all documents associated with all Early Access Programmes, including Real-World Data (RWD). They will operate as the primary client contact for content development. They will also facilitate process improvement to ensure all deliverables are of the highest quality, accurate and meet the clients' needs. What will your job look like?

• Creating content for a variety of deliverables for our clients including o Patient Consent and Assent formsWhat will you need to succeed?What will you get in return?
• Patient Information Sheets
• Early Access Program Protocols
• RWD Protocols
• Lay Summary Reports
• Investigator Brochures and updates
• Clinical Study Manuscripts
• Clinical Study Reports
• Understanding client expectations and meeting those expectations through teamwork, adherence to deadlines, scientific knowledge, and content development
• Working closely with internal operational teams ensuring content is accurate and tailored to the clients' needs
• Participating in internal and external meetings to confidently discuss content and the status of deliverables
• Monitoring assigned projects and managing own workload, taking ownership, and anticipating capacity issues and providing potential solution; including delegation of deliverables to medical writer vendors when required
• Management of medical writer vendors, including budget and invoice management
• Prior medical writing experience in clinical research/pharmaceutical industry/medical communications
• Experience working directly with clients/sponsors, preparing document timelines, organizing review cycles, and coordinating review meetings
• Bachelor's degree in a Healthcare/Science related subject
• Demonstrated understanding of early access programs, clinical research, the drug development process, and applicable regulatory guidelines and regulations
• Function as a team-player, highly organised, self-motivated, and extremely detail-oriented
• Strong oral and written communication skills, excellent interpersonal skills, and advanced computer literacy of MS Office Suite
• Ability to write at a level appropriate to the target audience
• Effective time management skills and ability to manage competing priorities
• Ability to work in a cross-functional environment
• Understanding of the integration of AI-enabled solutions to streamline documentation and reduce QC timelines We want you to do your best work! We care about our people's well-being, their personal development and providing a true work-life balance. Our benefits are aligned with our culture and values and are intended to maximize your experience working for us. Here are some of the benefits you can expect from working for Bionical Emas.
• 25 days of vacation
• Vacation days purchasing scheme
• 1 extra vacation day per each 3 years of service
• Discretionary Annual Bonus
• Sabbatical of 3 to 6 months (after 2 years of service)
• Free food and beverages at all offices
• Life Insurance
• Health Insurance and Employee Assistance Programme
• Employee Support Networks – help us continue to build on our inclusive culture
• Flexible and hybrid work Does this sound like you? It is time to apply, and we can't wait to hear from you! Even if you don't meet 100% of the requirements, be confident in yourself and don't hesitate to apply! PLEASE NOTE: We will be longlisting applications as soon as we receive them, so please apply early to register your interest We Are Bionical Emas Bionical Emas offers equal opportunities and is committed to diversity in its workplace and providing accessibility accommodations to applicants with physical and/or mental disabilities. If you are interested in applying for employment with Bionical Emas and need accommodation or special assistance, please let us know by sending an email with your request to the recruitment team at HR@bionicalemas.com. We Are Bionical Emas, where each person is unique. We celebrate individuality while encouraging our talents to work as a team. Together, we make a difference by powering an inclusive future for all. Be you, with us. Powering the patient journey