Find a job 
Featured Companies 
Featured Universities 
For Companies At a Glance
- Tasks: Write and edit high-quality clinical and safety documents for a leading pharmaceutical company.
- Company: Join a top-tier pharmaceutical firm in London, making an impact in healthcare.
- Benefits: Enjoy a hybrid work model, competitive salary, and opportunities for professional growth.
- Why this job: Be part of a dynamic team, contribute to vital projects, and enhance your writing skills.
- Qualifications: A life sciences degree is essential; some medical writing experience is preferred.
- Other info: This is a 12-month contract with a focus on compliance and regulatory standards.
The predicted salary is between 26000 - 36000 £ per year.
Location: White City, London
Contract: 12 Months / Hybrid 3 days onsite
Hours: 37.5 per week
Rates: £31,050 p/a
SRG are looking for an associate regulatory writer to join a leading pharmaceutical company based in London. The main purpose of this role is to write and/or edit under guidance high quality clinical and safety documentation.
Duties and Responsibilities
- To write and/or edit under guidance high quality clinical and safety documents: Clinical Study Protocols (CSP) and protocol amendments, non-registration Clinical Study Reports (CSR), Development Safety Update Reports (DSUR), Clinical Trial Registration Documents.
- May coordinate outsourced activities in RWS.
- Main sub-team representative at the Clinical Trial Team (CTT).
- Participate in planning of data analyses and presentation used in CSRs.
- May act as documentation consultant in CTTs to ensure compliance of documentation to internal company standards and external regulatory guidelines.
- May act as liaison between CTTs and publishing teams to ensure timely delivery of final documents for publishing.
- May contribute to development of processes within RWS.
- Maintain audit, SOP and training compliance.
Experience and Qualifications
- Education: Minimum university life science degree or equivalent is required. Advanced degree or equivalent education/degree in life sciences/healthcare is desirable.
- Languages: Fluent English (oral and written).
- Experience / Professional Requirement: Some medical writing experience or other relevant pharma industry experience combined with scientific and regulatory knowledge.
- Understanding of global regulatory environment and process (key regulatory bodies, key documents, approval processes, safety reporting requirements).
- Excellent communication skills (written, verbal, presentations).
- Understanding of biostatistics principles.
- Ability to prioritize and manage multiple demands and projects.
- Ability to define and solve complex problems (“Problem-solver”).
- Broad knowledge and future oriented perspective.
- Understanding of matrix environment.
- Global, cross-cultural perspective and customer orientation.
Associate Regulatory Writer Graduate employer: SRG
Contact Detail:
SRG Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Associate Regulatory Writer Graduate
✨Tip Number 1
Familiarise yourself with the key regulatory bodies and their guidelines. Understanding the specific requirements of organisations like the FDA or EMA can give you an edge in interviews, as it shows your commitment to the role and industry.
✨Tip Number 2
Network with professionals in the pharmaceutical industry, especially those involved in regulatory writing. Attend relevant webinars or local meetups to gain insights and potentially get referrals that could help you land the job.
✨Tip Number 3
Brush up on your communication skills, both written and verbal. Since the role involves writing high-quality clinical documents, being able to articulate your thoughts clearly during discussions or presentations will be crucial.
✨Tip Number 4
Gain a basic understanding of biostatistics principles. This knowledge will not only help you in the role but also demonstrate your ability to engage with complex data, which is often a key part of regulatory writing.
We think you need these skills to ace Associate Regulatory Writer Graduate
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights relevant experience in medical writing or the pharmaceutical industry. Emphasise any specific projects or documents you've worked on that relate to clinical study protocols or safety documentation.
Craft a Compelling Cover Letter: In your cover letter, express your enthusiasm for the role and the company. Mention your understanding of the regulatory environment and how your skills align with the responsibilities outlined in the job description.
Showcase Relevant Skills: Highlight your communication skills and problem-solving abilities in your application. Provide examples of how you've managed multiple projects or contributed to team efforts in previous roles.
Proofread Your Application: Before submitting, carefully proofread your CV and cover letter for any spelling or grammatical errors. A polished application reflects your attention to detail, which is crucial for a regulatory writer.
How to prepare for a job interview at SRG
✨Showcase Your Writing Skills
As an Associate Regulatory Writer, your writing ability is crucial. Bring samples of your previous work or be prepared to discuss your writing process and how you ensure clarity and compliance in your documents.
✨Understand Regulatory Guidelines
Familiarise yourself with key regulatory bodies and their guidelines. Be ready to discuss how these regulations impact the documentation process and demonstrate your understanding of compliance requirements.
✨Demonstrate Problem-Solving Abilities
Prepare examples of how you've tackled complex problems in past roles or projects. Highlight your analytical skills and your approach to finding solutions, especially in a fast-paced environment.
✨Communicate Effectively
Excellent communication is vital for this role. Practice articulating your thoughts clearly and concisely, both verbally and in writing. Be prepared to discuss how you would liaise with different teams to ensure timely document delivery.
