- Generate and edit medical content for regulatory documents including clinical protocols, investigator brochure (IB), DSUR, clinical study reports (CSRs), and regulatory responses or submissions.
- Collaborate with and/or provide oversight of external CRO medical writers as needed to ensure the timely completion of regulatory documents.
- Collaborate with internal teams in document kick-off meetings to align on the data content required, and help generate realistic timelines for document completion, including QC and publishing steps.
- Provide medical writing input in the generation and updating of protocol templates for early and later stage oncology protocols.
- Contribute to the preparation of clinical journal publications.
- Provide input on more efficient approaches to IB, DSUR, or CSR preparation.
- Stay current with industry trends, regulations, and guidelines to enhance the quality of written materials.
- Bachelor's degree in a relevant scientific field; advanced degree (e.g., MD, PhD) preferred.
- Proven experience in medical writing within the pharmaceutical or biotechnology industry, including medical oncology.
- Excellent writing, editing, and communication skills, with the ability to translate complex scientific information into clear and concise language.
- Familiarity with regulatory requirements and guidelines (e.g., ICH, FDA, EMA) for medical writing.
- Strong attention to detail and the ability to manage multiple projects simultaneously.
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Medical Writer
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Optimum Patient Care Oakington, United KingdomWe have an exciting opportunity for an experienced Medical Writer who is passionate about communicating real world clinical research. · The role is available with hybrid working from our offices in Oakington, Cambridgeshire or Aylsham, Norfolk. The position can also be worked rem ...
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Medical Writer - Cambridge, United Kingdom - invoX Pharma
Description
invoX is a research-driven global biopharmaceutical company using next-generation technology platforms to discover and develop innovative medicines that can change the lives of people around the world. Our vision is to be a leading global biopharmaceutical company with an advancing pipeline of products addressing the unmet healthcare needs of patients. To support our growth and success, we are seeking a Medical Writer to support our team on a contract basis. This position will be focused on producing high-quality medical content for various purposes, including regulatory documents, clinical trial reports, and manuscripts. As invoX continues to grow, this is a compelling opportunity to work in a fast-paced business. invoX is a wholly owned subsidiary of Sino Biopharmaceutical Limited, a Hong Kong listed global top 40 pharmaceutical company with more than 24,000 employees.Key Responsibilities
The Medical Writer will be responsible for researching, writing, and editing medical content in accordance with regulatory requirements and industry standards. They will collaborate with cross-functional teams to ensure the accuracy and compliance of written materials and contribute to the development of publication strategies. You will:Skills, Knowledge & Expertise
We are seeking a highly qualified and motivated individual with a strong background in medical writing and a passion for advancing healthcare through innovative research. The ideal contractor will possess a Bachelor's degree in a relevant scientific field, with an advanced degree (e.g., MD, PhD) being highly desirable. Proven experience in medical writing within the pharmaceutical or biotechnology industry is essential, along with excellent writing, editing, and communication skills. A keen attention to detail and the ability to manage multiple projects simultaneously are also key attributes we are looking for in potential candidates. Essential:Contract position
This is a contract position, so direct applicants will need to have their or set up their own limited companyPlease note: While we will consider candidates from all locations and remote working is a potential possibility, we have a strong preference for candidates based in the US or UK due to the location of the rest of our team. Ideally, to help facilitate our collaborative working culture, we would like a candidate to be based at one of our invoX sites in Cambridge or London
invoX Pharma was incorporated in March 2021 and is a wholly owned subsidiary of Sino Biopharm, a Hong Kong listed, global top 40 pharmaceutical company with more than 24,000 employees. UK-based invoX is an expanding biopharmaceutical company focusing on R&D, Clinical Development and Business Development activities in the UK, EU and US, with a core focus on oncology and respiratory therapeutics.
Our core team is made up of a multicultural international group of highly experienced individuals with life sciences and technology-centred backgrounds, all with a mutual passion and ambition for creating something different.
Mission: invoX's mission by 2026 is to be a globally recognised, fully integrated pharmaceutical company with an advancing pipeline of innovative products addressing unmet healthcare needs.
Purpose:We aspire to improve people's lives by creating access to innovative medicine.
Vision: To be a leading global pharmaceutical company through delivering innovative therapies for patients.
