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Description
Janssen Research & Development LLC, a Johnson & Johnson company, is recruiting for a Principal Medical Writing Scientist position, located in Springhouse, PA or San Diego, CA
The Principal Medical Writing Scientist is responsible for preparing sound scientific/clinical documents in assigned areas under minimal supervision using established templates and guidelines. 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 guidance''s, 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, or journal/authorship requirements and ethical publishing standards, as applicable; internal guidelines, styles; and electronic standards and guidelines. Takes a proactive or lead role on document preparation in terms of content and engages in scientific collaboration. Works collaboratively in a team environment, and takes a proactive role on multiple assigned projects with respect to timing, scheduling, tracking, and publication strategy as appropriate.
Decision-making includes: 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. Works as a member of a team under very minimal direction and is responsible for organizing own time in an optimal fashion. Proactive in identifying opportunities for greater productivity and participates in finding flexible solutions. She/he interacts in a manner that facilitates teamwork and productivity. 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, tracking, publication planning, and journal selection as appropriate. 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.
Qualifications
A PhD or equivalent in one of the biological sciences or related field with a minimum of 5 years of relevant pharmaceutical/scientific experience is required, or a Master degree or other advanced degree with a minimum of 6 years relevant pharmaceutical/scientific experience. A Bachelors degree may be considered with a minimum of 7 years of relevant pharmaceutical/scientific experience. Strong scientific/medical writing skills including the ability to interpret and organize scientific data is required. Must possess medical, scientific or healthcare writing experience. Experience writing clinical regulatory submission documents (including Clinical Study Reports, Investigator Brochures, Protocols, Integrated Summaries, Clinical Expert Reports, Responses to Regulatory Questions etc) is a preferences. Some research experience (including compilation of research reports or publications) in the pharmaceutical industry, or as part of a Ph.D., Pharm.D., or postdoctoral program, preferred. Also preferred is knowledge of experimental design; working knowledge of biostatistics; proficiency in computer word processing programs; knowledge of standard editorial/style conventions. Strong interpersonal and communication skills are a plus as the individual must be able to work in a team environment and coordinate with the team. This position will be located in Springhouse, PA or San Diego, CA
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-Pennsylvania-Spring House
Other Locations
North America-United States-California-San Diego
Organization
Janssen Research & Development, LLC. (6084)
Job Function
Medical Writing
Details:
Job Id:
33975114
Posted / Updated:
2/27/2012 3:53:54 AM
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