Vaccitech - Medical Writer (Associate Director/Director level) - Harwell, Oxfordshire, Remote/Hybrid
Vaccitech plc is a fast-growing biotech company. At only five years old we already have a development portfolio of six products, a partnered product that is in commercial production that has seen more than 3 billion doses administered worldwide and an IPO behind us. We are a publicly-listed clinical stage biopharmaceutical company that spun out of the University of Oxford’s Jenner Institute, one of the most prestigious vaccine research centres in the world. We discover and develop immunotherapeutic products and vaccines for the treatment and prevention of infectious diseases and cancer. Our achievements include co-inventing and jointly developing our COVID-19 vaccine candidate VTP-900, now Vaxzevria, which we assigned to Oxford University Innovation to facilitate the licensing of those rights to AstraZeneca. We have clinical studies to explore treatments for patients with HBV and HPV infections and are developing rapid and scalable manufacturing processes for our platforms.
In December 2021 Vaccitech acquired Avidea Technologies with exciting product candidates for oncology and autoimmunity based on the innovative SNAPvax platform, which has demonstrated unprecedented control over T cell induction. This gives us US operational presence in Maryland, complements Vaccitech’s established capabilities and reinforces our position as a fast-growing global leader in immunotherapies and vaccines. From March 2022 Vaccitech's UK headquarters will be moving to a state-of-the-art facility in the UK's leading science and innovation campus at Harwell. We conduct research globally and have ambitious plans in the UK and US, where we will continue to grow our teams over the coming months and years.
Leading our inhouse 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 Vaccitech; and provide proactive support to project and programme leadership for planning efficient work plans and timelines for medical writing deliverables.
Remote/hybrid working will be considered.
Experience and qualifications
The successful candidate 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 we can offer you
Vaccitech is a great place to work. We encourage an entirely flat structure with an open door policy to the senior leadership team. Our employees agree the culture and working environment is one of the best things about our 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 our rapid growth trajectory means you will have the opportunity to grow with us. We offer flexible forms of hybrid working, stock options to all employees, 25 days annual holidays increasing with length of service, an AXA Healthcare plan, Life Insurance and up to 5% pension contributions matched by the company.
How to apply
Please submit your application via our career portal on the link below.
For any queries about this role, please contact: email@example.com