Principal Medical Writing Scientist - Immunology
About the position
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are dedicated to helping people live full and healthy lives. Our focus is on treating, curing, and preventing some of the most devastating and complex diseases of our time. Janssen Research & Development is at the forefront of discovering and developing innovative medical solutions to address significant unmet medical needs across various therapeutic areas, including oncology, immunology, neuroscience, infectious diseases and vaccines, pulmonary hypertension, and cardiovascular and metabolic diseases. We are currently seeking a Principal Medical Writing Scientist to join our Regulatory Medical Writing team within Integrated Data Analytics & Reporting (IDAR) to support our Immunology therapeutic area. This position is open globally and can be located in various regions, including North America (Spring House, PA, Raritan, NJ, Titusville, NJ, or Canada) and Europe (United Kingdom, Ireland, Belgium, Netherlands, Germany, France, Spain, Italy, Poland, Bulgaria, or Switzerland). Remote work options may be considered on a case-by-case basis, subject to company approval. In this role, you will be responsible for preparing and finalizing clinical documents, including clinical study reports, investigator's brochures, study protocols, summary documents, risk management plans, regulatory responses, and briefing documents. You will lead cross-functional document planning and review meetings, interact with peer writers and colleagues from other departments, and have the ability to lead program-level or submission writing teams with supervision. Additionally, you will coach or mentor junior writers on document planning, processes, and content, providing peer review as needed. As a lead writer for a program, you will serve as the primary point of contact and champion for medical writing activities for the clinical team, responsible for planning, setting strategy, and leading the writing group for your assigned program. You will also maintain and apply your knowledge of industry, company, and regulatory guidelines to ensure compliance and quality in all documentation.
Responsibilities
• Prepare and finalize clinical documents such as clinical study reports, investigator's brochures, study protocols, summary documents, risk management plans, regulatory responses, and briefing documents.
,
• Lead cross-functional document planning and review meetings.
,
• Interact with peer writers and colleagues from other departments.
,
• Lead program-level or submission writing teams with supervision.
,
• Coach or mentor more junior writers on document planning, processes, content, and provide peer review as needed.
,
• Establish document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team, as needed.
,
• Serve as the primary point of contact and champion for medical writing activities for the clinical team if a lead writer for a program.
,
• Plan, set strategy, and lead writing group for assigned program.
,
• Maintain and apply knowledge of the industry, company, and regulatory guidelines.
Requirements
• A minimum of a Bachelor's or equivalent University/College degree is required.
,
• Advanced degree (Masters, PhD) preferred.
,
• A minimum of 6 years of relevant pharmaceutical/scientific experience is required.
,
• A minimum of 4 years of relevant medical writing experience is required.
,
• Authoring experience with investigator brochures, clinical study protocols, and clinical study reports is required.
,
• Experience with common technical document summaries is preferred.
,
• Strong leadership skills, both in time management and in project/process management is required.
,
• Must have strong attention to detail.
,
• Must have strong oral and written communication skills.
,
• Must be able to resolve complex problems under supervision.
Nice-to-haves
Benefits
Apply Now
At the Janssen Pharmaceutical Companies of Johnson & Johnson, we are dedicated to helping people live full and healthy lives. Our focus is on treating, curing, and preventing some of the most devastating and complex diseases of our time. Janssen Research & Development is at the forefront of discovering and developing innovative medical solutions to address significant unmet medical needs across various therapeutic areas, including oncology, immunology, neuroscience, infectious diseases and vaccines, pulmonary hypertension, and cardiovascular and metabolic diseases. We are currently seeking a Principal Medical Writing Scientist to join our Regulatory Medical Writing team within Integrated Data Analytics & Reporting (IDAR) to support our Immunology therapeutic area. This position is open globally and can be located in various regions, including North America (Spring House, PA, Raritan, NJ, Titusville, NJ, or Canada) and Europe (United Kingdom, Ireland, Belgium, Netherlands, Germany, France, Spain, Italy, Poland, Bulgaria, or Switzerland). Remote work options may be considered on a case-by-case basis, subject to company approval. In this role, you will be responsible for preparing and finalizing clinical documents, including clinical study reports, investigator's brochures, study protocols, summary documents, risk management plans, regulatory responses, and briefing documents. You will lead cross-functional document planning and review meetings, interact with peer writers and colleagues from other departments, and have the ability to lead program-level or submission writing teams with supervision. Additionally, you will coach or mentor junior writers on document planning, processes, and content, providing peer review as needed. As a lead writer for a program, you will serve as the primary point of contact and champion for medical writing activities for the clinical team, responsible for planning, setting strategy, and leading the writing group for your assigned program. You will also maintain and apply your knowledge of industry, company, and regulatory guidelines to ensure compliance and quality in all documentation.
Responsibilities
• Prepare and finalize clinical documents such as clinical study reports, investigator's brochures, study protocols, summary documents, risk management plans, regulatory responses, and briefing documents.
,
• Lead cross-functional document planning and review meetings.
,
• Interact with peer writers and colleagues from other departments.
,
• Lead program-level or submission writing teams with supervision.
,
• Coach or mentor more junior writers on document planning, processes, content, and provide peer review as needed.
,
• Establish document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team, as needed.
,
• Serve as the primary point of contact and champion for medical writing activities for the clinical team if a lead writer for a program.
,
• Plan, set strategy, and lead writing group for assigned program.
,
• Maintain and apply knowledge of the industry, company, and regulatory guidelines.
Requirements
• A minimum of a Bachelor's or equivalent University/College degree is required.
,
• Advanced degree (Masters, PhD) preferred.
,
• A minimum of 6 years of relevant pharmaceutical/scientific experience is required.
,
• A minimum of 4 years of relevant medical writing experience is required.
,
• Authoring experience with investigator brochures, clinical study protocols, and clinical study reports is required.
,
• Experience with common technical document summaries is preferred.
,
• Strong leadership skills, both in time management and in project/process management is required.
,
• Must have strong attention to detail.
,
• Must have strong oral and written communication skills.
,
• Must be able to resolve complex problems under supervision.
Nice-to-haves
Benefits
Apply Now