At a Glance
- Tasks: Create high-quality clinical documents and collaborate with diverse teams.
- Company: Join a leading pharmaceutical company focused on innovative therapies.
- Benefits: Hybrid work model, competitive salary, and opportunities for professional growth.
- Other info: Dynamic role with a focus on collaboration and stakeholder engagement.
- Why this job: Make a real impact in the CNS therapeutic area while developing your writing skills.
- Qualifications: Bachelor’s degree in Life Sciences or English/Communications; 6+ years of medical writing experience.
The predicted salary is between 60000 - 80000 £ per year.
The Senior Manager, Medical Writing will partner closely with cross-functional project teams to plan, develop, and deliver high-quality clinical and regulatory documents in compliance with global regulations, Good Clinical Practice (GCP), and internal SOPs. This role plays a key part within the Central Nervous System (CNS) therapeutic area, contributing both hands-on expertise and strategic oversight while collaborating with internal stakeholders and external partners. This hybrid position requires two days per week in our Maidenhead office.
Key Responsibilities
- Produce high-quality, on-time medical writing deliverables across the clinical development lifecycle.
- Independently plan, write, edit, and format key documents including clinical protocols, investigator brochures, clinical study reports, and integrated summaries of safety and efficacy.
- Represent Medical Writing on CNS project teams, collaborating across functions to support program goals and timelines.
- Facilitate efficient document review and finalisation processes for materials developed internally and/or by external vendors and contract writers.
- Oversee and provide direction to contract medical writers, ensuring consistency, quality, and adherence to standards.
- Engage confidently with a broad range of stakeholders, demonstrating strong stakeholder management, clear communication, and the ability to manage expectations with a sense of urgency.
- Prepare effectively for cross-functional meetings and maintain a strong "big-picture" mindset while delivering at pace.
- Contribute to the development and maintenance of medical writing SOPs and templates.
Required Qualifications
- Bachelor’s degree in Life Sciences with relevant writing expertise, or in English/Communications with strong scientific experience; advanced degree or professional certification preferred.
- 6+ years of experience as a medical writer within a pharmaceutical organisation preferably.
- In-depth knowledge of GCP, FDA regulations, ICH guidelines, and the drug development process.
- Demonstrated ability to manage multiple priorities in a fast-paced, deadline-driven environment.
- Proven ability to work collaboratively, communicate openly, and adapt writing style for different audiences.
- Flexibility to work across global time zones, with the majority of stakeholders based in U.S. Eastern Time (EST).
- High attention to detail and strong proficiency with Microsoft Word, Excel, and PowerPoint.
At Alnylam, we commit to an inclusive recruitment process and equal employment opportunity.
Sr Manager, Medical Writing in Maidenhead employer: Alnylam Pharmaceuticals
Contact Detail:
Alnylam Pharmaceuticals Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Sr Manager, Medical Writing in Maidenhead
✨Tip Number 1
Network like a pro! Reach out to your connections in the medical writing field and let them know you're on the hunt for a new role. You never know who might have the inside scoop on job openings or can put in a good word for you.
✨Tip Number 2
Prepare for interviews by brushing up on your knowledge of GCP, FDA regulations, and ICH guidelines. Be ready to discuss how your experience aligns with the responsibilities of the Senior Manager role, especially in the CNS therapeutic area.
✨Tip Number 3
Showcase your writing skills! Bring samples of your best work to interviews, especially those that demonstrate your ability to produce high-quality clinical documents. This will give potential employers a taste of what you can bring to the table.
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, it shows you’re genuinely interested in joining our team at Alnylam.
We think you need these skills to ace Sr Manager, Medical Writing in Maidenhead
Some tips for your application 🫡
Tailor Your Application: Make sure to customise your CV and cover letter to highlight your experience in medical writing, especially in the CNS therapeutic area. We want to see how your skills align with our needs, so don’t hold back on showcasing relevant projects!
Showcase Your Expertise: When detailing your experience, focus on your knowledge of GCP, FDA regulations, and ICH guidelines. We’re looking for someone who can hit the ground running, so let us know how you’ve applied this expertise in past roles.
Communicate Clearly: Your written application is a reflection of your communication skills. Keep it clear, concise, and professional. We appreciate a well-structured application that demonstrates your ability to convey complex information effectively.
Apply Through Our Website: We encourage you to submit your application through our website. It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it’s super easy to do!
How to prepare for a job interview at Alnylam Pharmaceuticals
✨Know Your Stuff
Make sure you brush up on your knowledge of GCP, FDA regulations, and ICH guidelines. Being able to discuss these topics confidently will show that you’re not just familiar with the requirements but also understand their importance in the medical writing process.
✨Showcase Your Experience
Prepare specific examples from your past roles where you’ve produced high-quality medical documents or managed multiple priorities. This will help demonstrate your hands-on expertise and strategic oversight, which are crucial for this role.
✨Engage with Stakeholders
Think about how you can effectively communicate and manage expectations with various stakeholders. Be ready to discuss how you’ve collaborated with cross-functional teams in the past and how you plan to do so in this role.
✨Be Ready for the Big Picture
During the interview, keep a strong 'big-picture' mindset. Be prepared to talk about how your contributions fit into the overall goals of the project and how you can maintain pace while ensuring quality in your deliverables.