CER Medical Writer

Criterion Edge; United States; Remote; USD 60,000 - 100,000; Full time

Job summary

An innovative firm is looking for a skilled Medical Writer to join their dynamic team. This exciting role offers the chance to contribute to impactful projects in the pharmaceutical and medical device sectors. You will collaborate with talented professionals to produce high-quality regulatory documents and scientific reports, ensuring they meet the highest standards. Ideal candidates will possess strong writing skills, a solid understanding of scientific principles, and the ability to work independently while managing project timelines. If you're passionate about medical writing and eager to make a difference, this opportunity is for you.

Qualifications

• 2+ years of medical writing experience in pharma or medical devices.
• BSc in life sciences or related field is required.
• Excellent written and oral communication skills.

Responsibilities

• Produce high-quality regulatory and scientific documents.
• Collaborate with project managers and writing team effectively.
• Participate in quality control checks and mentor junior staff.

Skills

Medical Writing

Communication Skills

Project Management

Problem-Solving

Attention to Detail

Scientific Knowledge

Education

Bachelor of Science in Life Sciences

Tools

Microsoft Office

Adobe Acrobat

Asana

SharePoint

Job description

Criterion Edge is seeking a remote candidate for the role of Medical Writer to join our best-in-class writing team and help take our customer focused writing services to new heights.

Employment Type and Location: Remote 1099 Contractor (Part Time/Full Time) located in India

Job Overview
In the role of Medical Writer, you will have the opportunity to work closely with other writers, project managers and support specialists to produce a wide variety of regulatory and scientific reports, plans, and other written deliverables for medical device, pharma/biotech, and in vitro device clients.

The ideal candidate is a writing professional looking to build on their relevant medical writing experience, scientific knowledge, and well-developed written and oral communication skills. We value proactive thinkers with the ability and desire to work in a multifunctional team setting, producing documents and reports that align with the highest regulatory, scientific, and professional standards.

Roles and Responsibilities
As a member of our project writing team, you will be responsible for producing assigned written documents and reports to a high standard. Your specific responsibilities include:

1. Direct responsibility for writing documents or document sections on assigned projects.
2. Able to organize own project workload and tasks, identify project needs and adhere to project timelines.
3. Understand client expectations and work to meet those expectations through teamwork, adherence to deadlines, problem-solving and scientific knowledge.
4. Effectively collaborate with other members of the project writing team.
5. Working with a Criterion Edge Project Manager, document your assigned tasks, time estimates and due dates into the Asana project plan. Provide weekly progress updates.
6. Ensure all data presented in the document are clear, complete, accurate, and concise. Ensure all statements and conclusions are integrated, balanced, supported by appropriate data, and consistent across all related documents.
7. Receive expert/scientific review comments and adjust the document content as required based on internal and external feedback.
8. Stay abreast of current medical writing best practices and relevant regulatory knowledge.
9. Proactively identify potential project risks and bring those forward to the overall project team to discuss and identify solutions.
10. Participate in quality control (QC) checks for accuracy following established internal QC processes.
11. Provide written and verbal feedback to junior staff and managers when appropriate.
12. When requested, serve as a project mentor to assist in the training and development of junior staff on your project team(s).
13. Establish and maintain effective, professional working relationships with co-workers, managers, and clients.
14. Demonstrate initiative and sound judgement when faced with less familiar project requirements and/or document situations or challenges. Seeks understanding and additional clarity from Project Lead and/or Project Management before proceeding.

Qualifications and Skills

1. 2+ years of direct writing experience in pharmaceutical, medical device, in vitro device or related academic fields.
2. Minimum of a BSc in a life sciences or related discipline / related field.
3. Advanced word processing skills, including Microsoft Office (including Word), Adobe Acrobat, Excel and collaborative document sharing platforms such as SharePoint; ability to learn and adapt to various IT systems.
4. Familiar with all current and applicable guidelines and regulations governing the assigned project.
5. Knowledge of and experience with systematic literature review (SLR) methodology and best practices, including Level 1 and Level 2 literature screening, data extraction and weighting and appraisal of data sets.
6. High level of English fluency or native English speaker, with excellent oral (including presentation) and written communication, including grammatical/technical writing skills.
7. Able to interact confidently with external stakeholders and communicate with others effectively and clearly.
8. Capable of working independently to achieve assigned project goals with minimal supervision.
9. Reliably produces high-quality written deliverables in accordance with customer and project requirements and agreed timelines.
10. Excellent attention to detail and accuracy.
11. Contributes, collaborates, shares responsibilities, and supports other team members to ensure success with tasks/projects.
12. Demonstrates scientific rigor and understanding of the scientific process in written documents.