This role collaborates closely with cross-functional teams, including Clinical Operations, Biostatistics, Medical Writing, and Regulatory Affairs, to support timely and compliant study execution
60 Katalyst Medical Writer Jobs Hiring Near You
This role collaborates closely with cross-functional teams, including Clinical Operations, Biostatistics, Medical Writing, and Regulatory Affairs, to support timely and compliant study execution
Clinical Data Manager
Medina, WA · On-site
This role collaborates closely with cross-functional teams, including Clinical Operations, Biostatistics, Medical Writing, and Regulatory Affairs, to support timely and compliant study execution.
Clinical Data Manager
Medina, WA · On-site
This role collaborates closely with cross-functional teams, including Clinical Operations, Biostatistics, Medical Writing, and Regulatory Affairs, to support timely and compliant study execution.
This role must effectively interface with team members from Statistics, Data Sciences, Pharmacovigilance and Patient Safety, Data Analytics, Medical Writing, Regulatory Publishing and Clinical ...
This role must effectively interface with team members from Statistics, Data Sciences, Pharmacovigilance and Patient Safety, Data Analytics, Medical Writing, Regulatory Publishing and Clinical ...
Clinical Data Manager
Chicago, IL · On-site
... Medical Writers, Regulatory representatives, etc.) * DM Project Management: With oversight, ensure data management deliverables are met on time. Utilize communication, available metrics reports ...
Clinical Data Manager
Chicago, IL · On-site
... Medical Writers, Regulatory representatives, etc.) * DM Project Management: With oversight, ensure data management deliverables are met on time. Utilize communication, available metrics reports ...
... Medical Writers, Regulatory representatives, etc.) * DM Project Management: With oversight, ensure data management deliverables are met on time. Utilize communication, available metrics reports ...
... Medical Writers, Regulatory representatives, etc.) * DM Project Management: With oversight, ensure data management deliverables are met on time. Utilize communication, available metrics reports ...
Collaborate with clinical operations, biostatistics, statistical programming, medical writing, scientific and regulatory teams to provide data management expertise in clinical trial planning and ...
Collaborate with clinical operations, biostatistics, statistical programming, medical writing, scientific and regulatory teams to provide data management expertise in clinical trial planning and ...
Provide input into, and mentor statistical programmers to provide input into documents produced by other functions (e.g., biostatisticians, data managers, medical writers, etc.) * records handling (e ...
Provide input into, and mentor statistical programmers to provide input into documents produced by other functions (e.g., biostatisticians, data managers, medical writers, etc.) * records handling (e ...
Provide input into, and mentor statistical programmers to provide input into documents produced by other functions (e.g., biostatisticians, data managers, medical writers, etc.) records handling (e.g ...
Provide input into, and mentor statistical programmers to provide input into documents produced by other functions (e.g., biostatisticians, data managers, medical writers, etc.) records handling (e.g ...
... Medical Writers, Regulatory representatives, etc.) * DM Project Management: With oversight, ensure data management deliverables are met on time. Utilize communication, available metrics reports ...
... Medical Writers, Regulatory representatives, etc.) * DM Project Management: With oversight, ensure data management deliverables are met on time. Utilize communication, available metrics reports ...
Clinical Data Manager
Raleigh, NC · On-site
Collaborate with clinical operations, biostatistics, statistical programming, medical writing, scientific and regulatory teams to provide data management expertise in clinical trial planning and ...
Clinical Data Manager
Raleigh, NC · On-site
Collaborate with clinical operations, biostatistics, statistical programming, medical writing, scientific and regulatory teams to provide data management expertise in clinical trial planning and ...
Collaborate with clinical operations, biostatistics, statistical programming, medical writing, scientific and regulatory teams to provide data management expertise in clinical trial planning and ...
Collaborate with clinical operations, biostatistics, statistical programming, medical writing, scientific and regulatory teams to provide data management expertise in clinical trial planning and ...
Provide input into, and mentor statistical programmers to provide input into documents produced by other functions (e.g., biostatisticians, data managers, medical writers, etc.) * Records handling (e ...
Provide input into, and mentor statistical programmers to provide input into documents produced by other functions (e.g., biostatisticians, data managers, medical writers, etc.) * Records handling (e ...
Provide input into, and mentor statistical programmers to provide input into documents produced by other functions (e.g., biostatisticians, data managers, medical writers, etc.) * records handling (e ...
Provide input into, and mentor statistical programmers to provide input into documents produced by other functions (e.g., biostatisticians, data managers, medical writers, etc.) * records handling (e ...
Principal Statistical Programmer
Edison, NJ · On-site
Provide input into, and mentor statistical programmers to provide input into documents produced by other functions (e.g., biostatisticians, data managers, medical writers, etc.) * records handling (e ...
Principal Statistical Programmer
Edison, NJ · On-site
Provide input into, and mentor statistical programmers to provide input into documents produced by other functions (e.g., biostatisticians, data managers, medical writers, etc.) * records handling (e ...
Provide input into, and mentor statistical programmers to provide input into documents produced by other functions (e.g., biostatisticians, data managers, medical writers, etc.) * records handling (e ...
Provide input into, and mentor statistical programmers to provide input into documents produced by other functions (e.g., biostatisticians, data managers, medical writers, etc.) * records handling (e ...
Lead statistical Programmer
Boston, MA · On-site
Collaborate with medical writing, clinical, and regulatory on study-level initiatives. * Support inspection and audit readiness by ensuring appropriate documentation, traceability, and ...
Lead statistical Programmer
Boston, MA · On-site
Collaborate with medical writing, clinical, and regulatory on study-level initiatives. * Support inspection and audit readiness by ensuring appropriate documentation, traceability, and ...
Medical Doctor (M.D), Doctor of Osteopathy (D.O.), or non-US equivalent of M.D. degree with ... Must possess excellent oral and written English communication skills. * 3+ years of experience.
Medical Doctor (M.D), Doctor of Osteopathy (D.O.), or non-US equivalent of M.D. degree with ... Must possess excellent oral and written English communication skills. * 3+ years of experience.
Medical Doctor (M.D), Doctor of Osteopathy (D.O.), or non-US equivalent of M.D. degree with ... Must possess excellent oral and written English communication skills. * 3+ years of experience.
Medical Doctor (M.D), Doctor of Osteopathy (D.O.), or non-US equivalent of M.D. degree with ... Must possess excellent oral and written English communication skills. * 3+ years of experience.
Medical Doctor (M.D), Doctor of Osteopathy (D.O.), or non-US equivalent of M.D. degree with ... Must possess excellent oral and written English communication skills. * 3+ years of experience.
Medical Doctor (M.D), Doctor of Osteopathy (D.O.), or non-US equivalent of M.D. degree with ... Must possess excellent oral and written English communication skills. * 3+ years of experience.
Collaborate with medical writing, clinical, and regulatory on study-level initiatives. * Support inspection and audit readiness by ensuring appropriate documentation, traceability, and ...
Collaborate with medical writing, clinical, and regulatory on study-level initiatives. * Support inspection and audit readiness by ensuring appropriate documentation, traceability, and ...
Katalyst Jobs Information
What are the key skills and qualifications needed to thrive as a Medical Writer, and why are they important?
To thrive as a Medical Writer, you need a strong background in life sciences or medicine, excellent written communication skills, and often an advanced degree such as a PhD, MD, or relevant certification. Familiarity with reference management software, medical literature databases, and regulatory guidelines like ICH or GPP is typically required. Attention to detail, the ability to interpret complex data, and collaboration skills set standout professionals apart in this role. These competencies ensure the production of accurate, compliant, and accessible medical documents crucial for regulatory approval, education, and communication in healthcare.
How does a Medical Writer typically collaborate with subject matter experts during a project?
Medical Writers frequently work closely with physicians, researchers, and regulatory specialists to ensure content accuracy and clarity. This collaboration often involves conducting interviews, reviewing scientific data, and incorporating expert feedback into drafts. Building strong professional relationships and maintaining clear communication are key for efficiently resolving technical questions and aligning final documents with project objectives. This teamwork is essential for producing high-quality, compliant materials that meet both scientific and regulatory standards.
What are medical writers?
Medical writers are professionals who create scientific documents related to healthcare, medicine, and the life sciences. They produce materials such as clinical study reports, journal articles, regulatory submissions, and educational content for healthcare professionals or the public. Medical writers must have a strong understanding of medical terminology, research methods, and regulatory guidelines. Their work helps communicate complex scientific information clearly, accurately, and in compliance with industry standards.
What is the difference between Medical Writer vs Clinical Writer?
| Aspect | Medical Writer | Clinical Writer |
|---|---|---|
| Credentials | Typically requires a degree in life sciences, healthcare, or related fields; certifications like AMWA or EMWA are common | Similar credentials; often holds degrees in life sciences with certifications in clinical research or writing |
| Work Environment | Works in pharmaceutical, biotech, or healthcare companies, often in offices or remote settings | Primarily in clinical research organizations, pharmaceutical companies, or hospitals, often in office or remote settings |
| Industry Usage | Used across pharma, biotech, medical device industries for regulatory, educational, and promotional content | Focused on clinical trial documentation, protocols, and reports within clinical research |
Medical Writers and Clinical Writers share similar backgrounds and work environments, often collaborating in healthcare and pharmaceutical sectors. The main difference lies in their focus: Medical Writers create a broad range of medical content, while Clinical Writers specialize in clinical trial documentation and reports.
What is it like to work at Katalyst?
Katalyst appears to be a collaborative and innovative company that values creativity and teamwork, fostering an environment where employees can share ideas and work together to achieve common goals.
The company's structure and work environment seem to be designed to support a dynamic and agile approach, with a focus on delivering high-quality results and driving business growth. Katalyst's mission is centered around helping businesses and organizations succeed through strategic partnerships and tailored solutions.
Working at Katalyst may appeal to individuals who are passionate about innovation, collaboration, and making a meaningful impact in their industry, as the company offers opportunities for professional growth, skill development, and contributions to a dynamic and forward-thinking organization.
The company's structure and work environment seem to be designed to support a dynamic and agile approach, with a focus on delivering high-quality results and driving business growth. Katalyst's mission is centered around helping businesses and organizations succeed through strategic partnerships and tailored solutions.
Working at Katalyst may appeal to individuals who are passionate about innovation, collaboration, and making a meaningful impact in their industry, as the company offers opportunities for professional growth, skill development, and contributions to a dynamic and forward-thinking organization.
What other companies are hiring for Medical Writer jobs?
What are the most popular jobs at Katalyst?
What are the most popular categories at Katalyst?
Job description
Responsibilities:
- The Clinical Data Manager (CDM) is responsible for the oversight, integrity, and quality of clinical trial data from collection through database lock
- The CDM ensures that data is accurate, consistent, and meets regulatory and protocol-specific requirements
- This role collaborates closely with cross-functional teams, including Clinical Operations, Biostatistics, Medical Writing, and Regulatory Affairs, to support timely and compliant study execution
- Design and review Case Report Forms (CRFs) and Electronic Data Capture (EDC) systems to ensure accurate and complete data capture aligned with the study protocol
- Develop and maintain data management plans (DMPs), data validation specifications, and CRF completion guidelines
- Oversee data cleaning activities, including the generation, review, and resolution of data queries in collaboration with clinical sites and study teams
- Perform ongoing data reviews to identify trends, inconsistencies, or protocol deviations
- Ensure adherence to data standards (e.g., CDISC, SDTM) and regulatory requirements (e.g., FDA, ICH-GCP)
- Manage database lock activities and contribute to the preparation of clinical study reports (CSRs)
- Serve as the primary point of contact for data management vendors and oversee their deliverables
- Participate in study team meetings and provide status updates related to data quality and timelines
- Support audit readiness and participate in regulatory inspections when required
- Bachelor's degree in Life Sciences, Computer Science, Health Informatics, or related field
- Minimum of 3-5 years of experience in clinical data management within a pharmaceutical, biotech, or CRO environment
- Proficiency in EDC platforms (e.g., Medidata Rave, Oracle InForm, Veeva, REDCap)
- Strong understanding of ICH-GCP, FDA regulations, and CDISC standards
- Experience with data listings, query management, edit check programming, and coding dictionaries (e.g., MedDRA, WHODrug)
- Excellent organizational, analytical, and problem-solving skills
- Strong communication and collaboration skills across cross-functional teams