Associate Consultant - Product Development & Regulatory Affairs

Entry Level Opportunity

SCENDEA is seeking an Associate Consultant to join our UK team in a full-time, office-based position. Scendea is a leading product development and regulatory consulting practice with over 20 years’ experience serving the pharmaceutical and biotechnology industry. We are committed problem solvers, redefining the meaning of customer service, with a focus on reducing time-to-market and minimising development costs.

Our international team offers strategic and operational support in the fields of quality/CMC, non-clinical/toxicology, clinical/medical and regulatory, which guide products efficiently from early development to marketing approval.

A combination of scientific excellence, industry experience, commercial awareness and a collaborative approach allow our expert team to solve complex issues associated with medicinal product development. Scendea has team members based in the UK, Ireland, the Netherlands and the US, who deliver innovative and high-quality solutions aligned to jurisdiction-specific regulatory requirements. The role will be an office-based role at our UK office in Bishop’s Stortford.

Your main responsibilities will be to:
- Undertake the writing of clinical trial and regulatory related documents.
- Perform literature/data searches and collate/summarise.
- Manage project documentation within company systems.
- Assess and analyse scientific data.
- Provide support to colleagues within the Scendea team.

You will have:
- A high scientific calibre with a life science focused BSc (or equivalent), and a higher degree (e.g. a life science focused MSc or PhD).
- Ability to work in a proactive and autonomous manner as well as being part of a team.
- Ability to balance competing priorities and complete work within a set timeframe.
- Good organisational skills with a high level of attention to detail.
- Excellent writing skills – you will be expected to summarise complex scientific data, thus facilitating the review of such data by external parties.
- Well-developed verbal communication and presentation skills.
- High level of computer literacy and competency in MS Office programs.
- Some experience of project management would be a significant advantage for this role. This could be project management of a research project (e.g., PhD) as an example.
- Any experience with regards to medical/scientific writing would be a major positive for this position.
- A general awareness of drug development and medical/regulatory affairs would be very favourably reviewed.
- Willingness to work flexible hours and travel for short periods, sometimes at short notice, within the UK or internationally.
- A clear ambition to progress your career in medical/scientific writing and regulatory consulting.
- Commercial experience is not a prerequisite for this position.

This is an entry level position and is ideal for someone wanting to start their career in medical/scientific writing and regulatory consulting. At Scendea, we will provide you with that opportunity and support your professional growth within a highly professional, internationally recognised team.

Our offer:

- A competitive salary plus bonus and 5% company contribution to pension.
- A challenging and stimulating position for a dynamic and competent scientist, wanting to contribute to a growing business and a rapidly expanding team.
- Coaching and mentoring to support your continuous learning, tailored to your individual needs
- Support of your professional development within a highly professional, internationally recognised dynamic team.
- A unique working environment driven by strong company values and a very high level of employee engagement across the international organisation.