Janssen Scientific Affairs, LLC, is recruiting for a Principal Medical Writer, Real World Evidence (RWE) Design and Analytics to be based in Titusville, NJ.
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 Scientific Affairs, LLC is committed to transforming patient and population health through scientific evidence across the Janssen pharmaceutical companies.
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 Writer, RWE Design and Analytics is responsible for preparing sound scientific/clinical documents under minimal supervision using established templates and guidelines.
• Responsible for the preparation of observational and interventional study protocols and reports, along with content contribution to abstracts, posters, manuscripts, white papers, policy documents and other scientific communications.
• The role will prepare documents within established timelines and in accordance with internal processes, regulatory guidelines, ethical publishing guidelines and company guidelines and styles in collaboration with Janssen researchers primarily in Real World Evidence and Health Economics & Outcomes Research.
• The individual will apply sound decision-making including recognizing how to best interpret and coordinate statistical and medical data into the appropriate organization and document structure to ensure quality and accuracy of content.
• He/she must be able to research, identify and incorporate appropriate references for written documents and/or work efficiently with Medical Information to do so.
• Occasionally, the role may oversee the work of contract medical writers and provide general medical writing guidance to teams. Qualifications
• Minimum of a Master’s degree in a related field required. PhD or other doctorate degree preferred. Primary Location
• A minimum of 4 years relevant medical, scientific and/or healthcare writing experience is required.
• The ability to interpret, analyze and summarize/visualize clinical and statistical data obtained in scientific research is required.
• A good understanding of experimental methods and study design is required.
• Experience in the real world evidence and health economics and outcomes research fields, including studies utilizing claims data and/or EMRs/EHRs is preferred.
• Superior writing and editing skills are required. Lead writer experience is preferred. Documents must be of high quality with respect to scientific content, organization, clarity, accuracy, format and consistency.
• Relevant pharmaceutical, health outcomes, clinical and/or scientific experience is preferred.
• Exposure to pharmaceutical strategies and tactics to meet both commercial and scientific communication objectives for a given product is preferred.
• An understanding of statistical analysis is preferred.
• Experience with templates and document management systems are required.
• Excellent skills in collaboration and influencing are required.
• Strong interpersonal and communications skills (both written and oral) are required.
• Proficiency with computer, word processing and presentation (i.e. PowerPoint) and basic Excel skills are required.
• Strong time-management and project planning skills are preferred.
• Experience with preparation and submission of publication deliverables (abstracts, posters, manuscripts) is preferred.
• Working knowledge of regulatory and commercial compliance issues relating to conducting research and dissemination of scientific information preferred.
• This position may require up to 10% domestic travel.
United States-New Jersey-TitusvilleOrganization
Janssen Scientific Affairs, LLC (6120)Job Function