Janssen Research & Development, LLC, a member of the Johnson & Johnson Family of Companies is recruiting for Regulatory Medical Writing Summer Interns to support the Neuroscience, Oncology, and Cardiovascular & Metabolism Therapeutic Areas and Established Products.
The Regulatory Medical Writing group comprises scientific and regulatory experts who provide high-quality clinical documents in support of Janssen products to address important unmet medical needs in oncology, immunology, neuroscience, infectious diseases and vaccines, and cardiovascular and metabolic diseases.
The Internship Program is focused on providing college students with practical industrial scientific and clinical experience. This position works as a member of a team under specific direction of a Regulatory Medical Writing manager for decisions.
The Regulatory Medical Writing Intern has an opportunity to:
- work collaboratively with Regulatory Medical Writing staff
- contribute to the preparation of sound scientific/clinical documents in assigned areas under direct supervision using established templates and guidelines
- ensure that sections conform to Janssen style and formatting guidelines
- participate in ongoing project team meetings
- be exposed to various other functions within the larger Global Clinical Development Operations group
- Provide support for conduct and reporting of clinical studies within neuroscience Regulatory Medical Writing
- Provide support for ongoing data transparency activities within oncology Regulatory Medical Writing (ie, preparation of redaction proposal packages for publication by European Medicines Agency in accordance with Policy 70)
- Provide support for Regulatory Medical Writing submission-related activities for cardiovascular compounds as well as Regulatory Medical Writing safety monitoring reports and submission activities for Established products.
- Candidates must be enrolled in an accredited college/university and pursuing a Bachelor degree or higher in biological science, medicine, or other health-related scientific field.
- Candidates must be available to work full-time (up to 40 hours/week) for 10 to 12 weeks from May to August.
- Students who have completed at least two years of college coursework will be considered.
- Candidates must be legally authorized to work in the United States and not require sponsorship for employment visa status (e.g. H1-B status) now or in the future.
- Demonstrated leadership is required.
- Candidates must be detail-oriented, highly organized and able to manage multiple tasks.
- Candidates must have the ability to work individually (independently) as well as on a team.
- Candidates need to be proficient with Microsoft Office, Word, Excel, and Power Point, and have strong interpersonal, oral and written communication skills. Additional technical competencies in SharePoint and other information technology systems are highly desirable, as is experience with PubMed databases and other literature databases.
- Candidates with ability to interpret and organize scientific data or preclinical laboratory experience are strongly preferred.
- A minimum G.P.A. of 3.0 is strongly preferred.
- Participation in campus/community service activities is desired.
The positions are based in Titusville, NJ (neuroscience), Springhouse, PA (oncology), or Raritan, NJ (cardiovascular & metabolism and established products) and require the candidates to work on site.Primary Location
United States-New Jersey-TitusvilleOrganization
Janssen Research & Development, LLC. (6084)Job Function