Medical Writer - Clinical Study Protocols/Reports/Investigator Brochures

Medical Writer is responsible for creating high-quality, scientifically accurate documents to support the development and commercialization of products at Cresilon. This role involves writing, editing, and reviewing clinical and marketing documents while ensuring compliance with industry standards, regulatory requirements, and company policies. The Medical Writer works closely with cross-functional teams, including regulatory, clinical, product development, and commercial team to ensure the clarity, accuracy, and effectiveness of all written materials.

Responsibilities:

Clinical Documentation:

• Write, edit, and review clinical study protocols, informed consent forms, clinical study reports (CSRs), and investigator brochures.
• Collaborate with clinical research teams to ensure the accuracy of scientific data and compliance with Good Clinical Practice (GCP) and International Council for Harmonization (ICH) guidelines.
• Assist in compiling and summarizing clinical data for regulatory submissions and post-market surveillance.

Marketing and Educational Materials:

• Work with marketing and product teams to develop scientifically accurate promotional materials, such as brochures, product monographs, white papers, and website content.
• Translate complex scientific data into clear, compelling, and compliant messaging for healthcare professionals, patients, and sales teams.
• Ensure all marketing materials are compliant with applicable medical device regulations and approved through proper review processes.

Scientific Publications:

• Prepare manuscripts, abstracts, posters, and presentations for publication in peer-reviewed journals and for scientific conferences.
• Assist subject matter experts in writing and editing scientific content, ensuring clarity and accuracy.
• Conduct literature searches to support scientific publications and regulatory submissions.

Compliance and Quality Control:

• Ensure all documents are compliant with relevant regulations (e.g., FDA, ISO 13485, EU MDR) and meet company quality standards.
• Coordinate the review and approval process of written documents by cross-functional teams, ensuring timely completion and submission.
• Maintain an up-to-date understanding of relevant regulatory guidelines and industry best practices for medical writing.

Cross-Functional Collaboration:

• Work closely with regulatory, clinical, quality, product development, and marketing teams to gather information, align messaging, and ensure document accuracy.
• Act as a liaison between internal stakeholders and external experts, such as key opinion leaders (KOLs) or contract research organizations (CROs), for document creation and review.
• Participate in project meetings to provide updates on writing progress and address document-related issues.

Project Management:

• Manage multiple writing projects simultaneously, ensuring deadlines are met and priorities are aligned with organizational goals.
• Track document progress and version control throughout the development process.
• Proactively address and resolve any issues related to the creation and approval of documents.

Requirements

Education:

·       Bachelor’s degree in life sciences, biomedical engineering, or a related field. Advanced degrees (MSc, PhD) in a scientific discipline are preferred.

Work Experience:

·       3+ years of experience in medical writing, preferably within the medical device or healthcare industry.

·       Experience writing clinical study documents and scientific publications.

·       Familiarity with regulatory guidelines (FDA, EMA, ISO 13485, EU MDR) for medical devices.

Skills and Competencies:

·       Strong technical writing and editing skills with the ability to present complex scientific concepts clearly and concisely.

·       Proficiency in Microsoft Office Suite (Word, Excel, PowerPoint), reference management software (e.g., EndNote), and electronic document management systems (EDMS).

·       Excellent organizational and project management abilities.

·       Attention to detail and ability to work under tight deadlines.

·       Strong communication and interpersonal skills, with the ability to work cross-functionally

Benefits

·       Paid Vacation, Sick, & Holidays 

·       Medical, Dental, and Vision Insurance, FSA: Dependent & Healthcare, Commuter & Parking Benefits, Long Term Disability Coverage

·       Company Paid Life and Short-Term Disability Coverage 

·       Work/Life Employee Assistance Program

·       401(k) & Roth Retirement Savings Plan with company match up to 5%

·       Monthly MetroCard Reimbursement

The salary range for this position is $85,000-$120,000.

Cresilon is an equal opportunity employer that is committed to diversity and inclusion in the workplace. We prohibit discrimination and harassment of any kind based on race, color, sex, religion, sexual orientation, national origin, disability, genetic information, pregnancy, or any other protected characteristic as outlined by federal, state, or local laws.

This policy applies to all employment practices within our organization, including hiring, recruiting, promotion, termination, layoff, recall, leave of absence, compensation, benefits, training, and apprenticeship. Cresilon makes hiring decisions based solely on qualifications, merit, and business needs at the time.