Job Title: Senior Medical Writer

 

Position Description:

Our client is seeking an experienced and highly skilled Senior Medical Writer to join their expert writing team. This role is fully remote and provides an opportunity to work on diverse regulatory and scientific writing projects within the medical device, pharmaceutical, and in vitro diagnostics industries. The ideal candidate must possess excellent writing skills, deep scientific knowledge, and the ability to create comprehensive medical documents. This position is suited for professionals with extensive medical writing experience who can take ownership of Clinical Evaluation Reports (CERs) and related regulatory documents from start to finish.

 

About the Company:

Our Client is a leading provider of regulatory and scientific writing services, supporting healthcare companies in achieving their global regulatory goals. Their expert team of writers and project managers leverage best-in-class writing processes, technology, and industry experience to produce high-quality documentation that meets compliance requirements efficiently and effectively.

 

Work Schedule:

• Flexible work schedule; workload varies based on project demand.
• Full-time contract position (approximately 40 hours per week).
• Writers typically manage two projects simultaneously.

 

Key Responsibilities:

• Independently write and edit regulatory and scientific documents, including Clinical Evaluation Reports (CERs), Clinical Evaluation Plans (CEP), Post-Market Clinical Follow-up (PMCF) plans and reports, and Summary of Safety and Clinical Performance (SSCP) reports.
• Ensure all documents are clear, accurate, and fully compliant with EU MDR (2017/745), FDA, ICH, and other regulatory guidelines.
• Conduct and interpret systematic literature reviews (SLRs), data extraction, and analysis to support regulatory writing projects.
• Collaborate with project managers, regulatory professionals, subject-matter experts, and other writers to align content with client expectations.
• Own the writing process from concept to final submission, including document revisions based on reviewer feedback.
• Maintain high standards of scientific rigor and regulatory compliance across all deliverables.
• Participate in internal quality control (QC) processes to ensure adherence to industry and client expectations.
• Stay up to date on regulatory and industry trends to enhance medical writing best practices.

 

Required Experience and Qualifications:

• Minimum 2 years of direct medical writing experience in the medical device or pharmaceutical industry.
• Proven experience in writing full CERs and related regulatory deliverables (CEP, PMCF, SSCP).
• Bachelor’s degree (BSc) or higher in Life Sciences, Biomedical Engineering, Pharmacy, or a related discipline.
• Strong ability to interpret and synthesize scientific data into clear and concise regulatory documents.
• Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), Adobe Acrobat, and SharePoint.
• In-depth knowledge of systematic literature review (SLR) methodology, including Level 1 and Level 2 screening, data extraction, and appraisal of literature.
• Familiarity with EU MDR, FDA 510(k), ISO 13485, and ICH guidelines.
• Ability to work independently, manage multiple projects, and meet strict deadlines.
• Excellent scientific accuracy and attention to detail.

 

Preferred Skills:

• Previous experience working with regulatory writing for medical devices.
• Knowledge of risk management documentation (ISO 14971:2019).
• Experience with pharmaceutical deliverables, including clinical study protocols and clinical study reports (CSRs).
• Proficiency in literature review databases (PubMed, Ovid) and regulatory software.
• Prior work experience in a large medical device or pharmaceutical company (e.g., Medtronic, IQVIA, or similar organizations) is a plus.

 

Language Requirements:

• High-level fluency in English (C1 Level or above).
• Must be able to effectively communicate with international clients and stakeholders.
• Strong oral and written communication skills, including technical and grammatical accuracy.

 

Compensation:

• Generous salary paid in USD or Local Currency according to contractor preference.
• All time off is unpaid; contractors manage their own schedules.

 

Additional Details:

• This position requires familiarity with medical terminology and regulatory discussions.
• Candidates must be able to engage in technical discussions with regulatory professionals and scientific experts.
• This role is not suitable for entry-level or junior writers, as it requires the ability to independently handle complex regulatory writing projects.
• Candidates who do not meet the required CER experience level will not be considered for this role.