Principal Medical Writing Scientist Job

Company Name:
Janssen Research & Development, LLC. (60
Raritan, NJ, US
Principal Medical Writing Scientist-7340140617
Janssen Research & Development, LLC is recruiting for a Principal Medical Writing Scientist position, located in Raritan or Titusville, NJ or Spring House, PA.
Janssen Research & Development, LLC develops treatments that improve the health and lifestyles of people worldwide. Research and development areas encompass novel targets in neurologic disorders, gastroenterology, oncology, infectious disease, diabetes, hematology, metabolic disorders, immunologic disorders, and reproductive medicine. This position will support the oncology therapeutic area.
The Principal Medical Writing Scientist is responsible for preparing sound scientific/clinical documents in the oncology area under minimal supervision using established templates and guidelines. This person prepares and finalizes basic and complex clinical documents with increasing independence. Documents must be of high quality in terms of scientific content, as well as organization per regulatory and internal guidances, clarity, and accuracy, with attention to format and consistency. Documents must be prepared within established timelines and in accordance with internal processes. Document content must adhere to regulatory guidelines, as applicable; internal guidelines, styles; and electronic standards and guidelines. She/he takes a proactive or lead role on document preparation in terms of content and engages in scientific collaboration. She/he works collaboratively in a team environment, and takes a proactive role on multiple assigned projects with respect to timing, scheduling, and tracking as appropriate.
Decision-making includes the following: recognizing how to best interpret and coordinate statistical and medical interpretation of data into the appropriate organization and document structure to ensure quality and accuracy of content, under very minimal supervision. This person works as a member of a team under very minimal direction and is responsible for organizing own time in an optimal fashion. She/he is proactive in identifying opportunities for greater productivity and participates in finding flexible solutions. She/he interacts in a manner that facilitates teamwork and productivity. This person takes an active role (with demonstrated ability to take on a lead role) on assigned projects with respect to planning of content, format, and timing of documents, as well as report scheduling and tracking as appropriate. She/he interacts with and may coordinate/supervise freelancers or external service providers as needed. The successful candidate will mentor/train junior writers or other peers. Demonstrates excellent listening skills and is proficient at sending clear, convincing, and well-tuned messages through a variety of media including but not limited to business discussions and agreements (one-on-one or larger groups) and electronic mail messages. The Principal Medical Writing Scientist will be able to negotiate with and influence others with regard to scientific content and process flow.
A PhD or equivalent in one of the biological sciences or related field with a minimum of 5 years of relevant pharmaceutical/scientific experience; a Master's degree or other advanced degree with a minimum of 6 years relevant pharmaceutical/scientific experience; or a Bachelor's degree with a minimum of 7 years of relevant pharmaceutical/scientific experience will be considered.
Strong scientific/medical writing skills including the ability to interpret and organize scientific data are required. Experience in writing regulatory submission documents (eg, Clinical Study Reports, Investigator Brochures, Protocols, Integrated Summaries, Clinical Expert Reports, Responses to Regulatory Questions, safety documents such as Risk Management Plans, and Developmental Safety Update Reports, etc.) is required.
A working knowledge of experimental design and biostatistics is preferred. Some research experience in academia or the pharmaceutical industry, or as part of a PhD, PharmD, or postdoctoral program, is desirable. Proficiency in computer word processing programs is required as well as knowledge of standard editorial/style conventions. Strong interpersonal and communication skills are required as the individual must be able to work in a team environment and coordinate with the team. This position will be located in Spring House, PA, Titusville, NJ, or Raritan NJ.
BE VITAL in your career. Be seen for the talent you bring to your work. Explore opportunities within the Johnson & Johnson Family of Companies.
Primary Location:
North America-United States-New Jersey-Raritan
Other Locations:
North America-United States-New Jersey-Titusville, North America-United States-Pennsylvania-Spring House
Janssen Research & Development, LLC. (6084)
Job Function:
Medical Writing
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