Senior Medical Writer
Job highlights
Identified by Google from the original job post
Qualifications
Bachelor’s degree in a scientific discipline is required
At least 10 years of medical writing experience, with a minimum of 5 years specializing in regulatory writing within the biotechnology or pharmaceutical industry
Proficiency in ICH guidelines, particularly for Investigator Brochures, Clinical Study Reports, INDs, and NDAs, with experience in writing at least one NDA or BLA
Additional experience in drug development areas such as clinical trial monitoring, data management, or statistics is advantageous
Benefits
$150-185K
You have access to our medical, dental, vision, and mental health programs, ensuring your health and wellness are taken care of
To support your continuous growth, we also provide a $1,500 per year education and professional certification fund
Responsibilities
The Senior Medical Writer is responsible for crafting and editing clinical and scientific documents, including statistical analysis summaries, literature reviews, abstracts, and posters, for regulatory submissions or sponsor use
Collaborating with sponsors and/or internal medical personnel and statisticians to develop clinical development plans, study protocols, and clinical study reports
Designing templates and shells for integrated clinical study reports in alignment with ICH guidelines, sponsor standards, and study protocols
Leading review meetings to address feedback from the team and/or the sponsor
Writing journal articles, abstracts, and posters in collaboration with statisticians and/or sponsors
Preparing clinical sections for INDs, NDAs, and other regulatory submissions
Drafting investigator brochures and annual reports, as well as briefing documents for regulatory submissions
Ensuring consistency in style, format, and content across all IND and NDA documents within a project
Performing additional duties as assigned
Job description
Compensation Range:
$150-185K
Welcome to IntePros, a certified woman-owned company specializing in innovative and results-oriented recruiting and staffing solutions. We take immense pride in genuinely understanding what drives and inspires exceptional individuals like you. Your success is our priority, and we are dedicated to actively shaping your long-term career journey. At IntePros, we believe in comprehensive well-being. You have access to our medical, dental, vision, and mental health programs, ensuring your health and wellness are taken care of. To support your continuous growth, we also provide a $1,500 per year education and professional certification fund. Diversity and inclusion are cornerstones of our company ethos. IntePros is proud to be an equal opportunity employer. We do not discriminate in employment on the basis of race, color, religion, sex, pregnancy, gender identity, national origin, ****** orientation, disability, age, veteran or military status, retaliation, or any other characteristic protected by law. We celebrate the rich tapestry of backgrounds and perspectives that make us stronger as a team. Please note that only qualified individuals being considered will be contacted. We appreciate your interest and look forward to potentially embarking on a transformative journey together.
Responsibilities
The Senior Medical Writer is responsible for crafting and editing clinical and scientific documents, including statistical analysis summaries, literature reviews, abstracts, and posters, for regulatory submissions or sponsor use. Key duties include:
• Collaborating with sponsors and/or internal medical personnel and statisticians to develop clinical development plans, study protocols, and clinical study reports.
• Designing templates and shells for integrated clinical study reports in alignment with ICH guidelines, sponsor standards, and study protocols.
• Leading review meetings to address feedback from the team and/or the sponsor.
• Writing journal articles, abstracts, and posters in collaboration with statisticians and/or sponsors.
• Preparing clinical sections for INDs, NDAs, and other regulatory submissions.
• Drafting investigator brochures and annual reports, as well as briefing documents for regulatory submissions.
• Ensuring consistency in style, format, and content across all IND and NDA documents within a project.
• Performing additional duties as assigned.
Education
• Bachelor’s degree in a scientific discipline is required.
• Graduate degree is preferred.
Experience
• At least 10 years of medical writing experience, with a minimum of 5 years specializing in regulatory writing within the biotechnology or pharmaceutical industry.
Skills
• Proficiency in ICH guidelines, particularly for Investigator Brochures, Clinical Study Reports, INDs, and NDAs, with experience in writing at least one NDA or BLA.
• Familiarity with electronic document platforms is preferred.
• Additional experience in drug development areas such as clinical trial monitoring, data management, or statistics is advantageous.