A truly unique role has arisen with a leading Biopharmaceutical company in Worthing, West Sussex. We are looking for a highly educated (MSc or PhD preferred) Scientist with experience of Protein Biochemistry / Immunology and its application within a commercial environment. This is a newly created position for a Technical Writer, working within the Development department of a company with a strong pipeline of vaccines at various stages from proof of concept through to licensing across different vaccines.
If you have a real interest in drug development, together with excellent data analysis and interpretation skills and the ability to provide a broad range of support to the regulatory submission process, this will be an excellent opportunity for you. The company offers a competitive salary, based on experience, and unparalleled career progression opportunities.
A pioneering UK-owned Pharmaceutical organisation specialising in the treatment and prevention of allergies. Their focus is on the vaccination and prevention of a wide range of conditions including hay fever and their products are fascinating, complex and ever-progressing. The company employs around 270 people in Worthing across development, manufacturing (bulk and patient-named) and commercial activities and has built an excellent reputation for providing career developing opportunities, challenging and engaging project work; plus a pleasant, vibrant working environment.
You will join a busy Development team which works closely with company’s Reg Affairs group and provides valuable interpretation of complex data to support the drug registration process, from proof of concept through to licensing and commercialisation. This is a broad, challenging role that requires meticulous attention to detail, strong communication skills and the ability to multitask. Full details will be provided on application; but in summary your role will include:
- Assessment of scientific (CMC) expectations from external requests (RFIs), planned company regulatory projects (such as future marketing authorisation applications, CTAs), guidance and in-house expectations with breakdown to requested tasks
- Co-ordination of data from CMC activities and to ensure effective planning and communication of expectations leading to on-time delivery
- The organisation and management of scientific data with key internal and external stakeholders to achieve regulatory, scientific and market driven objectives
- Interpret data (e.g. Immunoassay, ELISA etc) from development and QC, to provide reports or technical documents to meet regulatory requirements and current legislation
- Collate data for use in peer-reviewed publications
- Establish synergy between Development and related business areas (Regulatory, Manufacturing, Marketing, Quality and Clinical Development)
- Provide support at congresses and other opportunities to engage with external collaborators
- Competitive salary (to be discussed on application)
- 25 days' holiday
- Private medical cover
- Discretionary, non-contractual annual bonus
- Stakeholder pension plan
- Flexible working hours
- Life insurance scheme
- Long term disability scheme
- Commutable by car with free parking or walking distance of train station / bus routes
We are inviting candidates with a strong scientific background, combined with some commercial Pharmaceutical experience. You will ideally have a Masters or PhD in Biochemistry or similar (e.g. Immunology, or other protein-based analysis, including immunoassay techniques such as ELISA), together with excellent data analysis and technical writing skills. Knowledge of the regulatory submission process, and how to produce “fit for use” data to support the CMC aspects of the CTD, would be a strong advantage. We are looking for someone who enjoys collaborating with others, undertaking projects (both proactive and reactive) and wants to build strong expertise in the fascinating world of vaccines.