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For Companies At a Glance
- Tasks: As a Principal Medical Writer, you'll craft and edit crucial clinical documents with minimal supervision.
- Company: Join MMS, a top-rated CRO known for its innovative, data-driven approach in the pharma and biotech sectors.
- Benefits: Enjoy remote work flexibility and a supportive environment that values your contributions.
- Why this job: Be part of a globally recognised team with a 97% customer satisfaction rating and impactful projects.
- Qualifications: A degree in a scientific field and 6+ years of regulatory writing experience are essential.
- Other info: Mentorship opportunities available to help you grow within a collaborative team.
The predicted salary is between 43200 - 72000 £ 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 recognised as a leading CRO in Global Health & Pharma’s international awards programs for the last three consecutive years.
Responsibilities
- Under minimal supervision, critically evaluate, analyse, 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 clients to coordinate all facets of projects; competent communicator skills for projects.
- Contribute substantially to, or manage, 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
- Bachelor’s, Masters or PhD Degree in scientific, medical, clinical discipline or related field is required with at least 6 years of previous regulatory writing experience; Masters or PhD degree is preferred.
- 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 organisational 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.
- Not required, but experience with orphan drug designations and PSP/PIPs a plus.
Principal 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 Principal Medical Writer - Remote
✨Tip Number 1
Familiarise yourself with the specific regulatory documents mentioned in the job description, such as clinical protocols and investigator’s brochures. Understanding these documents will not only help you during interviews but also demonstrate your expertise in regulatory writing.
✨Tip Number 2
Network with professionals in the medical writing field, especially those who have experience with CROs. Engaging with them on platforms like LinkedIn can provide insights into the role and may even lead to referrals.
✨Tip Number 3
Showcase your leadership skills by discussing any previous experiences where you managed a project team or mentored other writers. This is crucial for the Principal Medical Writer role, so be prepared to share specific examples.
✨Tip Number 4
Stay updated on the latest trends and regulations in clinical research and drug development. Being knowledgeable about current practices will set you apart from other candidates and show your commitment to the field.
We think you need these skills to ace Principal Medical Writer - Remote
Some tips for your application 🫡
Understand the Role: Before applying, make sure to thoroughly understand the responsibilities of a Principal Medical Writer. Familiarise yourself with the types of documents you will be writing and the regulatory standards you need to meet.
Tailor Your CV: Highlight your relevant experience in regulatory writing and clinical study protocols. Make sure to include specific examples of your work that demonstrate your expertise in the required areas, such as leading teams or managing projects.
Craft a Compelling Cover Letter: Your cover letter should reflect your passion for medical writing and your understanding of the pharmaceutical and biotech industries. Mention your experience with regulatory submissions and how it aligns with MMS's mission and values.
Proofread and Edit: Ensure that your application materials are free from errors. Given the nature of the role, attention to detail is crucial. Have someone else review your documents to catch any mistakes you might have missed.
How to prepare for a job interview at MMS Holdings Inc.
✨Showcase Your Writing Skills
As a Principal Medical Writer, your writing skills are paramount. Bring samples of your previous work to the interview, especially regulatory documents you've authored. This will demonstrate your expertise and give the interviewers a clear idea of your writing style and proficiency.
✨Understand the Company’s Focus
Familiarise yourself with MMS's approach to clinical trials and regulatory submissions. Understanding their data-driven methodology and customer satisfaction rating will allow you to tailor your responses and show how your experience aligns with their values.
✨Prepare for Technical Questions
Expect questions about your experience with clinical study protocols and regulatory submissions. Be ready to discuss specific challenges you've faced in past projects and how you overcame them, as this will highlight your problem-solving skills and industry knowledge.
✨Demonstrate Leadership Experience
Since the role involves mentoring other writers and managing project teams, be prepared to discuss your leadership style. Share examples of how you've successfully led teams, managed timelines, and ensured high-quality outputs under pressure.
