Janssen Research & Development, LLC., a member of the J&J Family of Companies, is recruiting for a Senior Medical Writing Scientist to be located in Spring House, PA.
At the Janssen Pharmaceutical Companies of Johnson & Johnson, what matters most is helping people live full and healthy lives. We focus on treating, curing and preventing some of the most devastating and complex diseases of our time. And we pursue the most promising science, wherever it might be found.
Janssen Research & Development, LLC discovers and develops innovative medical solutions to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases. Please visit http://www.janssenrnd.com/ for more information.
We are Janssen. Our mission drives us. Our patients inspire us. We collaborate with the world for the health of everyone in it.
The Senior Medical Writing Scientist will support the Immunology therapeutic area and will:
• Prepare sound scientific/regulatory documents with supervision using established templates and guidelines.
• Interpret and coordinate statistical and medical interpretation of data into the appropriate organization and document structure to ensure quality and accuracy of content.
• Work as a member of a team with supervision. The Senior Medical Writer will require in-depth scientific knowledge and will follow guidelines used for the preparation of medical writing documents. This individual is an individual contributor, but may prove guidance to contractors.
• Prepare and finalize basic and complex clinical documents with supervision.
• Prepare documents of high quality in terms of scientific content, with attention to format, consistency, and accuracy.
• Prepare documents within established timelines and in accordance with internal processes.
• Prepare documents that adhere to regulatory guidelines, or journal/authorship requirements and ethical publishing standards, including internal guidelines and electronic standards and guidelines.
• Engage in scientific collaboration with clinical and other functional areas to ensure integrity of documentation.
• Provide a significant contribution for projects of low-medium complexity and take an increasingly active or lead role on assigned projects with respect to planning of content, format, scheduling, and tracking as appropriate.Qualifications
• A PhD or equivalent advanced degree with a minimum of 3 years of relevant pharmaceutical/scientific experience is required OR a Master's degree or equivalent advanced degree with a minimum of 4 years of relevant pharmaceutical/scientific experience is required OR a Bachelor's degree with a minimum of 5 years of relevant pharmaceutical/scientific experience is required
• Demonstrated ability to interpret and organize scientific data (e.g. written clinical and/or regulatory documents for drug development, published manuscripts, etc.) is required
• Experience in the pharmaceutical industry or related industry experience is required
• Experience with MS Office Suite (Excel, Word, PowerPoint) is required
• The ability to work well independently as well as part of a team is required
• Project management experience is preferred
• The ability to stay organized, manage time, and work on multiple documents/projects at once is required
• Experience using AMA, ICH, or similar guidelines is preferred
• Experience with medical writing document standards and processes is preferred
• Experience using document repository software (e.g. Documentum, ERIS, etc.) is preferred
• Research experience (including compilation of research reports or publications) in academia or the pharmaceutical industry or as part of a PHD, Pharm.D, or postdoctoral program is preferred
• This position is located in Spring House, PA and will require up to 10% travelPrimary Location
United States-Pennsylvania-Spring HouseOrganization
Janssen Research & Development, LLC. (6084)Job Function