The role is covered in the following locations: Manchester, Stockport, Warrington
This leading Med Comms agency are focused on delivering for both their clients but also for their employees too.
They understand that everyone is different, and believe in treating everyone as an individual, in turn providing excellent opportunities for people to develop their careers and skills across all of their disciplines.
This also means the agency are able to offer a unique working environment, where ideas are heard, giving everyone the opportunity to be recognised and valued for who they are, and what they can do.
This role involves being the point of contact for specific project deliverables, managing the technical and scientific aspects of leadership of designated client accounts/teams, aswell as being a key source of product/therapy area expertise.
You must use working knowledge of regulatory processes to take documents from inception to sign-off as efficiently as possible while ensuring high quality.
While taking responsibility for the delivery of multiple projects across client accounts, the production of clear, accurate, grammatically correct written work to meet the project/client brief, timelines and budget.
Key Duties and Responsibilities
- Manage, lead and motivate regulatory team members, adhering to Company policies and procedures.
- Coach and mentor more junior regulatory team members (Regulatory Writer/Associate Regulatory Writer), providing support and guidance on client and project related issues as required.
- Work with the Project Management team to develop or review budgets against project specifications; supporting tracking and managing project finances/reconciliations.
- Support the Project Management team bymonitoring the progress of all assigned projects against the agreed schedule and budget specification, liaising with the client to negotiate changes to the project specification/budget, if necessary.
- Efficiently manage resourcing for projects, managing competing projects and liaising with the Regulatory
- Highlight to senior colleagues any potential new projects, thus contributing to organic business growth.
- Work with senior team members to contribute to new business activities to support the future growth of Bioscript Regulatory, including, but not limited to, contributing to pitches and proposals or credentials presentations as appropriate.
- Provide support for senior colleagues in developing and implementing regulatory processes, document quality, regulatory strategy, client procedures, leading by example by implementing best practice and advising on approach to projects and compliance requirements
-Writing Director to engage freelancers as necessary. Flag capacity or bottlenecks with senior colleagues so that resource can be allocated most efficiently.
The person must have:
- A post-graduate qualification.
- A proven track record in medical or scientific writing, (ideally in a client-driven agency).
- Comprehensive medical knowledge, including an understanding of clinical trials, the
pharmaceutical industry, and drug development process.
- Experience of writing across a range of therapy areas.
(Areas of particular interest are ( oncology , haematological disorders, endocrinology , neurology , urology /mens health).
- Strong research skills and a sound knowledge of medical databases and search engines.
- Excellent communication skills, to support collaborative relationships with colleagues and clients.
- The confidence to support clients, managing the scope and organisation of complex deliverables.
- 3-5 years experience with leading documents.
- 25 Days annual leave plus bank holidays
- Private healthcare
- Life insurance
- Critical illness insurance
- Holiday exchange scheme
- Wellness fund (£300 a year for a fun activity or to learn a
new skill) or Simply Health Cash Plan
- Access to remote GPs,
physiotherapy, medical second opinions and counselling
with qualified counsellors)
- Cycle to work scheme
- Retail discounts (clothing, household, travel, shopping,
days out etc.)
- Enhanced maternity/paternity leave
- Leave for charity work
- £50 birthday donation to charity
- Two bonus rounds a year (~10% per year)
- Pension contributions