Senior Medical Writer
Established in 2005, we have developed a deserved reputation for being a leading consultancy, with a wealth of regulatory and scientific knowledge and considerable experience in both leadership and management.
Our growing team of over 80 qualified professionals have a pharmaceutical and/or regulatory background. We provide services to over 130 organisations, enabling them to achieve their strategic and operational development objectives.
Our expertise and flexible working approach ensure the provision of a highly motivated team who interact effectively with clients and regulators globally, to support both single issue and long-term commitment to projects.
We are looking to expand our Medical Writing team and are currently looking for an experienced Senior Medical Writer to join us on a permanent basis.
This position can be based remotely or from our offices
The Senior Medical Writer will be fully responsible for the creation, authoring, and management of documentation for global regulatory submissions according to appropriate regulations, standards, guidelines (ICH and GXP), and company/client requirements.
- Create and update regulatory documentation for submission to regulatory authorities according to appropriate regulations, standards, guidelines (ICH and GXP), and company/client requirements, keeping to agreed timelines
- Provide support to Regulatory Consultants authoring regulatory documents
- Collaborate with interdisciplinary teams, international client functions, vendors, publishing, and Regulatory Consultants
- The ability to think logically and understand complex ideas and data
- Ensure consistency, completeness and adherence to agency guidelines, internal/client work instructions and SOPs throughout regulatory documentation
- Prioritise multiple tasks in a fast-paced environment while keeping within agreed timelines
- Stay current with industry practices, regulatory requirements, and medical developments that affect regulatory medical writing
- Develop Medical Writing plans and timelines to meet project and client goals
- Evaluate, contribute to and review SOPs, guidelines, and work instructions to ensure regulatory documentation are standardised and adhere to relevant guidelines
- Conduct literature searches to support Regulatory Applications
- Take responsibility for company activities, eg, company wide training on medical writing as appropriate
- Operate as subject matter expert in Medical Writing with responsibility for training and mentoring colleagues as appropriate.
Qualifications / Experience
- Educated to Minimum BSc level, PhD or equivalent preferred.
- Extensive experience working within Regulatory Medical Writing.
- Experienced within writing Regulatory documentation, including Scientific Advice, PIPs, iPSP, ODD, Protocols, IBs, CSRs, IMPDs, IND Sections of ICF, MA’s (NDA/BLA/MAA) M2 overviews and summaries
- Good work ethic & strategic mindset
- Provide strategic input, set appropriate milestones, and monitor progress towards results
- Taking responsibility for the completion of tasks/documents within a project
- Understanding our consultancy business model and contributing to the business development process when required.
We are a forward-thinking regulatory affairs consultancy, and takes the time to understand individual needs and find creative solutions for any regulatory challenge.