Senior Analyst, Immunology Regulatory Medical Writing
Are you a passionate and experienced medical writer with a background in immunology? Do you thrive in a fast-paced and dynamic environment? Johnson & Johnson is seeking a Senior Analyst for our Immunology Regulatory Medical Writing team to support our mission of improving patient outcomes through innovative medical solutions. As a Senior Analyst, you will play a crucial role in ensuring the accuracy and compliance of our regulatory documents in the field of immunology. We are looking for a highly organized and detail-oriented individual with strong writing skills and a deep understanding of immunology. Join us in making a difference in the lives of patients around the world.
- Conduct thorough research and analysis to support the development of accurate and compliant regulatory documents in the field of immunology.
- Write and edit medical content for regulatory submissions, such as clinical study reports, investigator brochures, and clinical protocols, ensuring accuracy and adherence to regulatory guidelines.
- Collaborate with cross-functional teams, including clinical development, regulatory affairs, and medical affairs, to obtain necessary information and ensure alignment on messaging and content.
- Stay up-to-date with the latest developments in immunology and regulatory requirements to ensure compliance and accuracy in all written materials.
- Create and maintain templates, style guides, and other resources to support consistent and high-quality medical writing.
- Review and provide feedback on documents written by junior medical writers to ensure accuracy, clarity, and compliance.
- Collaborate with external partners and vendors, as needed, to support the development and submission of regulatory documents.
- Effectively manage multiple projects and deadlines in a fast-paced and dynamic environment.
- Proactively identify and address potential issues or areas for improvement in medical writing processes and procedures.
- Represent the Immunology Regulatory Medical Writing team in cross-functional meetings and discussions, providing expert input and guidance on medical writing-related topics.
- Mentor and train junior medical writers on best practices in medical writing and regulatory requirements.
- Adhere to company policies and procedures, including those related to data privacy and confidentiality.
- Embody Johnson & Johnson's values and commitment to improving patient outcomes through innovative medical solutions.
Advanced Degree In Immunology Or A Related Field: The Senior Analyst Should Possess A Phd Or Equivalent Degree In Immunology Or A Related Field Such As Biochemistry, Molecular Biology, Or Pharmacology. This Advanced Degree Will Provide The Necessary Scientific Expertise To Understand And Communicate Complex Immunology Concepts In Regulatory Medical Writing.
Regulatory Writing Experience: The Ideal Candidate Should Have At Least 5 Years Of Experience In Regulatory Medical Writing Within The Pharmaceutical Or Biotechnology Industry. This Experience Should Include Preparation Of Clinical Study Reports, Protocols, And Regulatory Submissions For Immunology-Related Products.
Knowledge Of Regulatory Guidelines And Requirements: The Senior Analyst Should Have A Strong Understanding Of Global Regulatory Guidelines And Requirements For Drug Development, Particularly In The Field Of Immunology. This Will Ensure That All Written Materials Are Compliant With Regulatory Standards And Can Be Successfully Submitted For Approval.
Excellent Communication And Writing Skills: Strong Written And Verbal Communication Skills Are Essential For This Role. The Senior Analyst Must Be Able To Effectively Communicate Complex Scientific Information To Various Stakeholders, Including Regulatory Agencies, Clinical Teams, And Cross-Functional Teams Within The Company.
Attention To Detail And Adaptability: Regulatory Medical Writing Requires A High Level Of Attention To Detail, As Even Small Errors Can Have Significant Impacts On The Approval Process. The Senior Analyst Should Also Be Adaptable And Able To Work In A Fast-Paced And Dynamic Environment, As Regulatory Requirements And Guidelines Are Constantly Evolving.
Communication Skills
Project Management
Attention to detail
Quality Control
Scientific research
Regulatory compliance
FDA regulations
Cross-Functional Collaboration
Medical Writing
Clinical Data Analysis
writing proficiency
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Attention to detail
Teamwork
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Senior Analyst, Immunology Regulatory Medical Writing in Raritan, NJ 08869, USA is between $110,000 and $140,000 per year. However, this can vary depending on the specific company, years of experience, and other factors such as education and certifications.
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Johnson & Johnson is an investment holding company with interests in health care products. It engages in research and development, manufacture and sale of personal care hygienic products, pharmaceuticals and surgical equipment. The company operates through the following business segments: Consumer, Pharmaceutical and Medical Devices.
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