Medical Writer in Manchester

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.

At Bionical Emas, you will have the chance to develop your career while working with an outstanding team of people. Our shared values create a unique culture that guides our actions and defines who we are. You will be a part of a welcoming, flexible, and supportive culture that values trust and belonging. We believe that creating opportunities for our people to develop their skills is crucial to our growth and success.

We are looking for a (Senior) Medical Writer 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 and 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; Patient Consent and Assent forms, 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 solutions; including delegation of deliverables to medical writer vendors when required.
• Management of medical writer vendors, including budget and invoice management.

What will you need to succeed?

• 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.

What will you get in return?

• 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.

We encourage and hire people with diverse backgrounds, voices, beliefs, and perspectives into our growing global workforce. We do not discriminate on the basis of actual or perceived race, color, creed, religion, national origin, ancestry, citizenship status, age, sex or gender (including pregnancy, childbirth, and pregnancy-related conditions), gender identity or expression (including transgender status), sexual orientation, marital status, military service and veteran status, physical or mental disability, genetic information, or any other characteristic protected by applicable federal, state or local laws and ordinances.

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.