Janssen Research & Development, LLC., a member of the J&J Family of Companies, is recruiting for a Principal Medical Writing Scientist to be located in Springhouse, 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 Principal Medical Writing Scientist will support the Immunology therapeutic area and will:
• Prepare and finalize basic and complex scientific/clinical documents as assigned with minimal supervision. Documents must be of high quality in terms of scientific content, as well as organization per regulatory and internal guidance's, clarity, and accuracy, with attention to format and consistency using established templates. Documents must be prepared within established timelines and in accordance with internal processes.
• Make decisions that impact data interpretation and presentation in documents that will be viewed by external authorities.
• Decide on strategies for the best project management approach within process/timeline constraints and appropriate deviations from normal practice to meet unique challenges.
• Provide guidance to team with regard to content as appropriate, as well as processes, timelines, and scientific integrity.
• May provide guidance to contractors and oversee the work of other medical writers, external contractors, and document specialists supporting a project.
• May manage the work of document/project team members without authority over them.
• Work collaboratively in a team environment with minimal direction and take a proactive role on multiple assigned projects with respect to timing, scheduling, and tracking, as appropriate.
• Contribute scientifically and strategically and may lead submission-level, strategic activities for writing team.
• Proactively identify opportunities for greater productivity and participate in finding flexible solutions.
• Demonstrate excellent listening skills and be proficient at sending clear, convincing, and well-tuned messages through a variety of media including but not limited to business discussions (one-on-one or larger groups) and e-mail messages.
• Negotiate with and influence others with regard to scientific content and processes.Qualifications
• Bachelor’s degree with a minimum of 7 years of relevant medical writing experience is required OR a Master degree or equivalent advanced degree with a minimum of 6 years relevant medical writing experience is required OR a PhD or equivalent with a minimum of 5 years of relevant medical writing experience is required
• Strong scientific/medical writing skills including the ability to interpret and organize scientific data is required
• Experience in writing clinical regulatory submission documents, such as Clinical Study Reports, Investigator’s Brochures, Clinical Study Protocols, CTD Summary Documents (i.e., Efficacy and Safety Summaries, Clinical Overviews, etc.), Responses to Regulatory Questions, Briefing Documents, and safety documents (e.g. Risk Management Plans, etc.) is required
• A working knowledge of study design and biostatistics is preferred
• Experience in using applicable word processing (i.e., MS Word, etc.) software is required
• Experience working on cross-functional teams in a highly matrixed environment is required
• Project management experience is preferred
• In-depth knowledge of writing guidelines (e.g. ICH, FDA, AMA, etc.) used for the preparation of clinical documents is required
• Immunology therapeutic area experience is preferred
• Knowledge of the end-to-end drug development process is required
• This position will be located in Springhouse, PA and will require up to 10% domestic travelPrimary Location
United States-Pennsylvania-Spring HouseOrganization
Janssen Research & Development, LLC. (6084)Job Function