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 Brighton 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 Brighton
✨Get Involved in Local Research Communities
Tap into local biotechnology meetups and research forums. These are great places to mingle with industry professionals, share your passion, and even discover unadvertised job openings. It's all about getting your face known in the field!
✨Leverage University Alumni Networks
If you're a recent grad, don’t underestimate the power of your university’s alumni network! Reach out to alumni working in biotechnology to gather tips about job openings at companies like G&L Scientific. You'd be surprised how willing people are to help out a fellow grad!
✨Show Off Your Projects
Curate a portfolio showcasing any research projects or internships you've completed in biotechnology. This tangible evidence of your skills can really impress employers when you chat with them at networking events or interviews. It's about making that killer first impression!
✨Stay Up-to-Date with Industry Trends
Biotech is a fast-paced field, so keeping yourself updated with the latest advancements is crucial. Attend industry conferences, webinars, or workshops to broaden your knowledge and meet potential employers. Plus, it’ll give you fantastic talking points for your interviews at places like G&L Scientific!
We think you need these skills to ace Regulatory Medical Writer in Brighton
Some tips for your application 🫡
Show Off Your Lab Skills:In the biotechnology field, it's super important to highlight your lab experience in your CV. Be sure to mention specific techniques or instruments you've mastered (think PCR, gel electrophoresis, etc.) and any relevant projects you've worked on. This will show G&L Scientific that you have the hands-on skills they need.
Tailor Your Technical Skills:Make sure to emphasise your technical skills, especially those relevant to the biotechnology sector. Include any software tools or programming languages you've used, like R or Python for data analysis, which could be key for this role at G&L Scientific.
Craft a Compelling Cover Letter:Since this is a full-time role, your cover letter should reflect not only your passion for biotechnology but also your long-term career ambitions. Share why you're excited about the work that G&L Scientific does and how you envision contributing to their goals. This shows that you’re not just looking for any job, but you're genuinely invested in this opportunity.
Include Your Papers and Projects:If you've published any papers or contributed to significant projects, mention them! These documents can boost your application and provide tangible evidence of your expertise in the biotechnology field. Don’t forget to link to any relevant publications or project summaries—this can set you apart from other candidates.
How to prepare for a job interview at G&L Scientific
✨Brush Up on Lab Techniques
Since you're eyeing a full-time gig in biotechnology, make sure you're well-versed in the lab techniques relevant to the role. Be ready to talk about PCR, CRISPR, or any specific methods mentioned in the job description at G&L Scientific. You might even be asked to demonstrate your understanding of these processes.
✨Know Your Bioinformatics Tools
Get comfortable with bioinformatics tools that are commonly used in the industry, like BLAST or Bioconductor. These are key in biotechnology, and having hands-on experience or at least familiarity can set you apart. Prepare to discuss any relevant projects you've worked on, especially if they involved data analysis or genomic research.
✨Show Your Teamwork Skills
Biotech often involves collaboration across multiple disciplines. Be ready to share stories that highlight your teamwork and communication skills, especially in research projects. Think about working with different teams at university or any internships – this is where you can show how well you fit into G&L Scientific's culture.
✨Research Recent Biotech Innovations
Stay updated on the latest trends and breakthroughs in biotechnology. Knowing what's happening in the field can help you engage in more meaningful discussions during your interview. Bring up recent articles or advancements that excite you, especially those related to the work being done at G&L Scientific. This shows your passion for the industry!
