Medical Writer

In this role you will be writing regulatory and clinical documents such as clinical study reports and DSURs. You will be providing expertise in Medical Writing, leading the in house Medical Writing function.

**Client Details**

Our client is focusing on becoming a market leader in vaccines and other treatments for various infectious diseases and cancer.

**Description**

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 needto 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 resolvingproject-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 medicalwriting deliverables.

**Profile**

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 thedrug 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, InvestigatorBrochures, 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 ICHGCP and current clinical trial legislation and current medical/ scientific/ manuscript writing guidance.

**Job 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 getwholly 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 youwill 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 bythe company.