Medical Writer

Clear Point Consultants; Boston (MA); On-site; USD 83,000 - 124,000; Part time

Benefits offered by this job

Potential extension

Contract position

Job summary

Clear Point Consultants is seeking a Medical Writing Science Manager for an initial 2-month contract to join a collaborative clinical development team and support high-quality clinical and regulatory documents.

The role requires translating complex data into clear scientific narratives, leading medical writing for studies, coordinating input from stakeholders, and contributing to development plans in a fast-paced, cross-functional environment.

Qualifications

• Ph.D. or equivalent advanced degree in a relevant scientific or clinical discipline.
• Approximately 4+ years of relevant experience in medical writing, clinical research, drug development, or a related field.
• Demonstrated experience writing and editing clinical and regulatory documents.
• Strong clinical knowledge and understanding of clinical development and clinical research.
• Ability to analyze, interpret, and summarize complex clinical and scientific data.
• Experience translating extensive research data into clear, concise, and scientifically rigorous documents.
• Experience with clinical regulatory documents such as CSR, protocols, IBs.

Responsibilities

• Author moderately complex clinical and regulatory documents in collaboration with cross-functional partners.
• Serve as the Medical Writing lead for moderately complex clinical studies.
• Support clinical teams with the review and interpretation of study data and help address questions related to study results and documentation.
• Develop clear, concise key messages and scientific narratives for documents.
• Analyze and synthesize clinical and non-clinical data from multiple sources to develop accurate documents.
• Ensure consistency of medical and scientific information across related documents and studies within a clinical program.
• Contribute scientific and clinical expertise to clinical development plans and other program-level documents.
• Coordinate input from multiple stakeholders and manage document development timelines and deliverables.
• Participate in process improvements and development of procedures related to Medical Writing.
• Apply strong project management and organizational skills to manage multiple priorities in a fast-paced, cross-functional environment.

Skills

Medical writing

Clinical development

Regulatory writing

Project management

Cross-functional collaboration

Data interpretation

Stakeholder management

Education

Ph.D. or equivalent

Job description

Initial 2-month contract | Potential for extension or conversion

We are seeking a Medical Writing Science Manager to join a collaborative clinical development team supporting the preparation of high-quality clinical and regulatory documents.

This is a highly cross-functional opportunity for a scientific professional with strong clinical knowledge and writing skills who can analyze complex clinical and non-clinical information, identify key messages, and translate years of research data into clear, concise, scientifically accurate documents.

What You’ll Do

• Author moderately complex clinical and regulatory documents in collaboration with Clinical Development, Medical, Regulatory, Biostatistics, and other cross-functional partners.
• Serve as the Medical Writing lead for moderately complex clinical studies.
• Support clinical teams with the review and interpretation of study data and help address questions related to study results and documentation.
• Develop clear, concise key messages and scientific narratives for clinical and regulatory documents.
• Analyze and synthesize clinical and non-clinical data from multiple sources to develop accurate, audience-appropriate documents.
• Ensure consistency of medical and scientific information across related documents and studies within a clinical program.
• Contribute scientific and clinical expertise to clinical development plans and other program-level documents.
• Coordinate input from multiple stakeholders and manage document development timelines and deliverables.
• Participate in process improvements and development of procedures related to Medical Writing.
• Apply strong project management and organizational skills to manage multiple priorities in a fast-paced, cross-functional environment.

Key Qualifications

• Ph.D. or equivalent advanced degree in a relevant scientific or clinical discipline.
• Approximately 4+ years of relevant experience in medical writing, clinical research, drug development, or a related field.
• Demonstrated experience writing and editing clinical and regulatory documents.
• Strong clinical knowledge and understanding of clinical development and clinical research.
• Ability to analyze, interpret, and summarize complex clinical and scientific data.
• Experience translating extensive research data into clear, concise, and scientifically rigorous documents.
• Experience with clinical regulatory documents such as:
• Clinical Study Reports (CSRs)
• Clinical study protocols
• Investigator's Brochures (IBs)
• Broad understanding of drug development, study design, biostatistics, pharmacology, regulatory requirements, and medical terminology.
• Excellent written and verbal communication skills.
• Strong collaboration and stakeholder-management skills, with the ability to work effectively across multiple functions.
• Strong project management, organization, and prioritization skills.
• Ability to work independently, identify solutions, and manage competing priorities with appropriate guidance.