- Chance to be a part of a business aiming to be a market leader
- Work as a Medical Writer in a business wanting to treat infectious diseases
About Our Client
Our client is focusing on becoming a market leader in vaccines and other treatments for various infectious diseases and cancer.
Leading the in house medical writing function, the successful candidate will provide medical writing expertise for multiple products and projects. This will include interfacing cross functionally to ensure accurate and timely completion and delivery of information and review of scientific publications or clinical regulatory submissions. Serving as the scientific writing expert for the entire company, your key stakeholders will be medical, clinical, manufacturing, programme management, research, immunology, regulatory affairs and QA.
As part of your job you will write, or have input into, documents for submission to regulatory authorities, including briefing documents, clinical development plans, previous human experience summaries, human pharmacology summaries, investigator brochures, study protocols, model informed consents, interim and final clinical study reports, common technical documents (CTDs) clinical/non-clinical overviews and summaries, safety update/aggregate reports and integrated summaries of safety and efficacy. You will need to coordinate quality control reviews of documents and maintaining audit trails of changes; provide input on data analysis planning and interpretation; serve as the primary contact for medical writing assignments, negotiating deliverable timelines and resolving project-related issues; liaise with, and management of, external medical writing consultants who are providing support to the business; and provide proactive support to project and programme leadership for planning efficient work plans and timelines for medical writing deliverables.
The Successful Applicant
The successful Medical Writer will be degree educated in a scientific discipline, with a PhD being a strong preference. You will have extensive medical writing experience within the clinical research field together with a demonstrated understanding of the drug development process, and applicable regulatory guidelines. You will ideally have experience in a variety of indications, particularly infectious diseases and oncology as well as experience with writing a variety of documents (Clinical Study Reports, Investigator Brochures, protocols/amendments, safety narratives, Developmental Safety Update Reports, scientific publications, briefing books. Experience in early phase (I-¬‐II) studies and vaccine development is required as well as an excellent working knowledge of ICH GCP and current clinical trial legislation and current medical/ scientific/ manuscript writing guidance.
What's on Offer
They encourage an entirely flat structure with an open door policy to the senior leadership team. Other employees agree the culture and working environment is one of the best things about the business. This position would suit somebody who wishes to get wholly embedded with a single company and grow an internal medical writing function from the ground up. As part of a small high growth business you will get the opportunity to be involved in many different areas and their rapid growth trajectory means you will have the opportunity to grow with the business. Our client offer flexible forms of hybrid working, stock options to all employees, 25 days annual holidays increasing with length of service, Life Insurance and up to 5% pension contributions matched by the company.