Principal Medical Writing Scientist - Immunology
About the position At the Janssen Pharmaceutical Companies of reputed company, 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 reputed company diseases of our time. Janssen Research & Development is at the forefront of discovering and developing innovative reputed company 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 reputed company Integrated Data Analytics & Reporting (IDAR) to support our Immunology therapeutic area. This position is open globally and can be located in various regions, including reputed company 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 reputed company cross-functional document planning and review meetings, interact with peer writers and colleagues from other departments, and have the ability to reputed company 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 reputed company writer for a program, you will serve as the primary reputed company 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 reputed company 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.
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- reputed company cross-functional document planning and review meetings.
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- Interact with peer writers and colleagues from other departments.
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- reputed company program-level or submission writing teams with supervision.
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- Coach or mentor more junior writers on document planning, processes, content, and provide peer review as needed.
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- Establish document timelines and strategies in accordance with internal processes, with some mentorship from functional management and clinical team, as needed.
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- Serve as the primary reputed company of contact and champion for medical writing activities for the clinical team if a reputed company writer for a program.
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- Plan, set strategy, and reputed company writing group for assigned program.
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- 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.
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- Advanced degree (Masters, PhD) preferred.
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- A minimum of 6 years of relevant pharmaceutical/scientific experience is required.
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- A minimum of 4 years of relevant medical writing experience is required.
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- Authoring experience with investigator brochures, clinical study protocols, and clinical study reports is required.
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- Experience with common technical document summaries is preferred.
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- Strong leadership skills, both in time management and in project/process management is required.
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- Must have strong attention to detail.
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- Must have strong oral and written communication skills.
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- Must be reputed company to resolve reputed company problems under supervision.
reputed company-to-haves
Benefits
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