At a Glance
- Tasks: Create impactful clinical and regulatory documents for the pharmaceutical industry.
- Company: Join G&L Scientific, a leading independent scientific consultancy.
- Benefits: Global opportunities, inclusive culture, and a commitment to equality.
- Other info: Work in a supportive environment that values diversity and talent.
- Why this job: Make a difference in drug development while honing your writing skills.
- Qualifications: BSc or BA with relevant experience; 10 years in medical writing preferred.
The predicted salary is between 56700 - 69300 £ per year.
Regulatory Medical Writer
G&L Scientific is the world’s fastest-growing independent scientific consultancy providing Pharmaceutical and Biotechnology clients throughout the world with expert Regulatory Affairs consultancy and Quality Assurance solutions.
As demand for our services and solutions continues to increase, we have an exciting new opportunity for Regulatory Medical Writers to join our global team.
This permanent role is available globally.
The Role
- Authoring and preparing clinical and regulatory documents, including:
- Investigator’s Brochures,
- Study Protocols/ Informed Consent Forms (ICF),
- General Investigational Plan,
- Non-clinical Overviews (CTD section 2.4),
- Clinical Overviews (CTD Section 2.5),
- Non-clinical Summaries (CTD Section 2.6),
- Clinical Summaries (CTD Section 2.7),
- Paediatric Investigation Plans,
- Orphan Drug Designations,
- Clinical Study Reports (CSR), ISS and ISE,
- PSUR/ DSUR.
Candidate Requirements
- A BSc degree with relevant writing experience or a BA degree with relevant scientific/medical knowledge and expertise.
- A minimum of ten (10) years’ experience in medical writing.
- Extensive skills in English grammar, FDA and ICH regulations and guidelines and AMA style guide.
- A demonstrable, high degree of independence with effective presentation, proofreading, interpersonal, and leadership skills.
- Strong proficiency in all Microsoft products including the ability to solve technical problems with Word templates.
- Familiarity with principles of clinical research and ability to interpret and present clinical data and other complex information.
- A solid understanding of drug development processes, preclinical development, toxicology etc.
- Experience with effectively managing and meeting timelines/project objectives.
- Expertise in multiple therapeutic areas.
G&L Scientific is an equal opportunities employer and welcomes applicants from all sections of the community regardless of their gender, religious belief, political opinion, sexual orientation, disability, age, marital status or race.
We recruit based on talent alone and firmly believe that an individual’s background should play no part in the recruitment and selection process.
G&L is committed to everyone having the right to work in an environment free from the threat of discrimination, intimidation, harassment, and abuse.
All employees at G&L share the responsibility to challenge discriminatory behaviour and promote equality of opportunity.
Regulatory Medical Writer in Basingstoke employer: G&L Scientific
G&L Scientific is an exceptional employer, offering a dynamic work environment in West London where regulatory professionals can thrive. With a strong commitment to employee growth and development, the company provides opportunities to work on diverse projects within biotechnology and pharmaceuticals, fostering a culture of collaboration and innovation. Employees benefit from a supportive atmosphere that values inclusivity and encourages creative problem-solving, making it an ideal place for those seeking meaningful and rewarding careers in regulatory affairs.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Medical Writer in Basingstoke
✨Unlock Networking Opportunities
Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like G&L Scientific. These are goldmines for making connections and learning about job openings before they hit the mainstream job boards.
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Get involved with organisations such as the Royal Pharmaceutical Society or your local pharmaceutical professionals' network. Being an active member can boost your credibility and may even lead to job referrals in top organisations like G&L Scientific.
✨Leverage Internships for Full-time Roles
If you can, consider pursuing internships in the pharmaceutical industry, especially with companies like G&L Scientific. These opportunities often pave the way for full-time positions and allow you to demonstrate your capabilities firsthand.
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When you're applying for roles, don't rush it! Take the time to customise your applications for specific positions, showcasing relevant skills and experiences that align with what G&L Scientific is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Regulatory Medical Writer in Basingstoke
Some tips for your application 🫡
Showcase Your Relevant Experience:When applying for a role in the pharmaceutical industry, it's crucial to highlight any relevant experience you have. Whether that's internships, lab work, or even related coursework, make sure to weave this into your CV and cover letter. We want to see how your background aligns with the role you're applying for at G&L Scientific!
Emphasise Your Understanding of Regulations:The pharmaceutical industry is heavily regulated, so it's important to indicate your familiarity with industry standards and regulations. In your cover letter, mention any training or certifications you've received that are relevant, or discuss projects where you’ve navigated compliance. This will show G&L Scientific that you're not just a fit for the job but also a safety-conscious candidate!
Tailor Your CV to Be Result-Driven:Craft your CV to highlight quantifiable achievements, especially if you have previous roles in pharmaceuticals or related fields. Use metrics to demonstrate your impact, such as improved processing times or successful project completions while working on trials. This analytical approach will resonate well with hiring managers at G&L Scientific!
Convey Your Passion for the Industry:In your cover letter, express why you are passionate about working in the pharmaceutical sector. Whether it’s your desire to contribute to groundbreaking drug research or improve patient outcomes, let it shine through! At G&L Scientific, we value candidates who are truly enthusiastic about their work—you might just stand out from the crowd.
How to prepare for a job interview at G&L Scientific
✨Understand the Science
Make sure you brush up on key pharmaceutical concepts and recent developments in the industry. You might get asked some technical questions during the interview at G&L Scientific that show your grasp of drug development processes or regulatory requirements, so be ready to discuss them clearly.
✨Showcase Relevant Experience
If you have any hands-on experience or internships in a laboratory setting, be sure to highlight these in your responses. Think about the projects you worked on, the methodologies you used, and the impact you made. It's all about telling a story that connects your background to the role you're applying for.
✨Know Their Products
Take some time to familiarise yourself with G&L Scientific’s product range and recent breakthroughs. Understanding their portfolio not only shows your enthusiasm for the role but also allows you to ask insightful questions that demonstrate your interest in actively contributing to their projects.
✨Be Ready for Regulatory Scenarios
In a full-time pharmaceutical role, understanding the regulatory landscape is crucial. Prepare for situational questions that may test your problem-solving skills concerning compliance and safety standards. You could be asked how you'd handle a hypothetical issue regarding a drug’s market release, so think through your approach.
