At a Glance
- Tasks: Lead medical writing strategy and ensure high-quality deliverables for clinical development.
- Company: CSL Behring, a global leader in biotherapeutics dedicated to saving lives.
- Benefits: Comprehensive benefits package, including health support and a focus on well-being.
- Other info: Join a diverse team committed to inclusion and innovation in the biopharmaceutical industry.
- Why this job: Make a real impact in healthcare by driving innovative therapies for patients worldwide.
- Qualifications: 5+ years of medical writing experience; advanced degrees preferred.
The predicted salary is between 54000 - 66000 £ per year.
The Principal Medical Writer is a key leadership position responsible for determining and driving the medical writing strategy for one or more Programs within Clinical Development. The incumbent is accountable for the efficient preparation of high quality, strategically aligned medical writing deliverables that support the clinical development, clinical safety and regulatory requirements of a clinical program. He or she is also responsible for the messaging strategy across a program of work, for the provision of strategic input into the development of clinical development plans and submission plans, and for analyzing proposed plans, programs, individual studies and related documents for their ability to deliver the information required by the target audience (ie, regulatory authority) in a compelling fashion with accuracy and consistency. This role has global responsibilities, participation in global teams and interaction with regulatory agencies in multiple regions.
Main Responsibilities & Accountabilities:
- Leads the Medical Writing contributions to assigned clinical Programs
- Drives and develops the messaging strategy for the assigned Program(s) to ensure effective communication
- Accountable for medical writing deliverable quality and ensures adherence to departmental procedures / practices, and industry / international standards
Minimum Qualifications and Experience:
- Bachelor’s degree in science related discipline with 5+ years of medical writing experience within the biopharmaceutical industry or contract research organization
- Post-graduate qualifications desired (PhD or MD preferred)
Competencies:
- Comprehensive understanding of medical writing for clinical development, including the documents required at each stage and their associated regulatory requirements
- Comprehensive understanding of medical writing processes and standards
- Excellent written, verbal and presentation skills
- Demonstrated track record in cross-functional, multicultural and international clinical trial teams
- Proven effective verbal, written and presentation skills
- Mastery of the English language, with a comprehensive understanding of English grammar and punctuation
- Expert MS Office skills with a special focus on word processing, tables, spreadsheets, presentations, graphics and templates
- Prior experience with submissions in Common Technical Document (CTD) format
- Proven ability to work effectively both independently or in a team setting
- Proven effective influencing skills, able to lead without formal authority
- Excellent organizational and time management skills with demonstrated ability to manage several projects simultaneously
- Ability to analyze critically and synthesize complex scientific information from a range of scientific disciplines and clinical therapeutic areas
- Successful track record of leading complex clinical / regulatory writing projects
- Excellent understanding of ICH-GCP
- Detail-oriented
Principal Medical Writer in Maidenhead employer: CSL
CSL Seqirus is an excellent employer that fosters a collaborative and inclusive work culture, making it an ideal place for a Global Financial Analyst. With a strong focus on employee growth and development, the company offers numerous opportunities for professional advancement while providing a hybrid working model that promotes work-life balance. Located in Speke, Liverpool, employees benefit from a vibrant community and the chance to engage with diverse teams across the globe, enhancing both personal and professional experiences.
StudySmarter Expert Advice🤫
We think this is how you could land Principal Medical Writer in Maidenhead
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Dive into industry-specific events like pharmaceutical conferences and seminars, where you can meet hiring managers from companies like CSL. 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 CSL.
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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 CSL is looking for. A tailored application can really make you stand out!
We think you need these skills to ace Principal Medical Writer in Maidenhead
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 CSL!
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 CSL 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 CSL!
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 CSL, 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 CSL
✨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 CSL 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 CSL’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.
