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- Tasks: As a Senior Medical Writer, you'll create and edit crucial clinical documents with minimal supervision.
- Company: Join MMS, a top-rated CRO known for its innovative, data-driven approach in the pharmaceutical industry.
- Benefits: Enjoy remote work flexibility and be part of a globally recognised team with a 97% customer satisfaction rating.
- Why this job: This role offers a chance to impact drug development while working in a supportive, collaborative environment.
- Qualifications: You need 3-5 years of regulatory writing experience and a degree in a scientific or medical field.
- Other info: Mentorship opportunities available for aspiring medical writers looking to grow their skills.
The predicted salary is between 48000 - 84000 £ per year.
MMS is an innovative, data-focused CRO that supports the pharmaceutical, biotech, and medical device industries with a proven, scientific approach to complex trial data and regulatory submission challenges. Strong industry experience, technology-enabled services, and a data-driven approach to drug development make MMS a valuable CRO partner, creating compelling submissions that meet rigorous regulatory standards. With a global footprint across four continents, MMS maintains a 97 percent customer satisfaction rating, and the company has been recognized as a leading CRO inGlobal Health & Pharma’sinternational awards programs for the last three consecutive years. For more information, visit or follow MMS on LinkedIn .
Responsibilities
- Under minimal supervision, the Medical Writer will critically evaluate, analyze, and interpret the medical literature to select primary resource materials for adequate study design, statistical significance, scientific rigor and absence of bias
- Write and edit clinical development documents, including but not limited to, clinical protocols, investigator’s brochures, clinical study reports, subject consent forms, integrated safety and efficacy summaries, Module 2.7.1, 2.7.2, 2.7.3, 2.7.4, and 2.5 documents, presentation materials and publications to medical journals
- Complete writing assignments in a timely manner
- Maintain timelines and workflow of writing assignments
- Practice good internal and external customer service
- Highly proficient with styles of writing for various regulatory documents
- Expert proficiency with client templates & style guides
- Interact directly and independently with client to coordinate all facets of projects; competent communicator skills for projects
- Contribute substantially to, or manages, production of interpretive guides
- Take ownership of a given assignment, proactively consulting other project team members and other department representatives for information or guidance as necessary
- Mentor medical writers and other members of the project team who are involved in the writing process
Requirements
- At least 3 years of previous experience in the pharmaceutical industry
- Must have at least 3-5 years of industry regulatory writing and clinical medical writing experience
- The ideal candidate would hold a Bachelors, Masters, or Ph.D. in scientific, medical, clinical discipline
- Substantial clinical study protocol experience, as lead author, required
- Experience leading and managing teams while authoring regulatory documents with aggressive timelines
- Experience in regulatory submissions (clinical study reports) presented to regulatory authorities a plus
- Understanding of clinical data
- Exceptional writing skills are a must
- Excellent organizational skills and the ability to multi-task are essential prerequisites
- Candidate must be an expert in MS Word, Excel, PowerPoint, and related word processing tools
- Experience being a project lead, or managing a project team
- Strong understanding of federal regulations, Good Clinical Practices, and ICH guidelines a plus
- Substantial clinical study protocol experience, as lead author, required
- Experience leading and managing teams while authoring regulatory documents with aggressive timelines
- Not required, but experience with orphan drug designations and PSP/PIPs a plus
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Senior Medical Writer (Remote) employer: MMS Holdings Inc
Contact Detail:
MMS Holdings Inc Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Senior Medical Writer (Remote)
✨Tip Number 1
Familiarise yourself with the latest regulatory guidelines and standards in the pharmaceutical industry. This knowledge will not only help you during interviews but also demonstrate your commitment to staying updated in a rapidly evolving field.
✨Tip Number 2
Network with professionals in the medical writing community, especially those who have experience in regulatory submissions. Engaging with them on platforms like LinkedIn can provide valuable insights and potentially lead to referrals.
✨Tip Number 3
Prepare to discuss specific examples of your previous work, particularly any clinical study protocols or regulatory documents you've authored. Being able to articulate your contributions and the impact they had will set you apart from other candidates.
✨Tip Number 4
Showcase your ability to manage timelines and workflows effectively. Be ready to share strategies you've used in past projects to ensure deadlines are met, as this is crucial for the role of a Senior Medical Writer.
We think you need these skills to ace Senior Medical Writer (Remote)
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly understand the responsibilities and requirements of the Senior Medical Writer position. Familiarise yourself with the types of documents you will be expected to write and the regulatory standards involved.
Tailor Your CV: Customise your CV to highlight relevant experience in regulatory writing and clinical medical writing. Emphasise your expertise in creating clinical protocols, study reports, and other key documents mentioned in the job description.
Craft a Compelling Cover Letter: Write a cover letter that showcases your passion for the pharmaceutical industry and your understanding of the role. Mention specific experiences that demonstrate your ability to meet the job's requirements, such as leading teams or managing aggressive timelines.
Proofread Your Application: Ensure that your application is free from grammatical errors and typos. A well-written application reflects your attention to detail, which is crucial for a Medical Writer. Consider asking a colleague to review your documents before submission.
How to prepare for a job interview at MMS Holdings Inc
✨Showcase Your Writing Skills
As a Senior Medical Writer, your writing skills are paramount. Bring samples of your previous work to the interview, especially regulatory documents you've authored. Be prepared to discuss your writing process and how you ensure clarity and compliance with industry standards.
✨Demonstrate Industry Knowledge
Familiarise yourself with the latest trends and regulations in the pharmaceutical industry. Be ready to discuss how your experience aligns with MMS's focus on data-driven approaches and regulatory submissions. This shows that you're not just qualified but also genuinely interested in the field.
✨Prepare for Scenario-Based Questions
Expect questions that assess your problem-solving abilities and how you handle tight deadlines. Prepare examples from your past experiences where you successfully managed multiple projects or overcame challenges in writing clinical documents.
✨Highlight Team Leadership Experience
Since the role involves mentoring other writers and managing project teams, be sure to discuss your leadership style and any relevant experiences. Share specific instances where you guided a team through a complex project or improved workflow efficiency.