Senior Analyst, Controlled Document Services - (Job Number: 0805724)

Senior Analyst, Controlled Document Services - (Job Number: 0805724) DescriptionOrtho-McNeil Janssen Scientific Affairs, L.L.C. is dedicated to providing medical information and consultative support to a number of J&J's pharmaceutical companies. The company's mission is to create the pre-eminent model of scientific excellence in the promotion of public health. The Senior Analyst, Controlled Document Services will have responsibility for the development and revision of standard operating procedures (SOPs) and associated forms for OMJSA. Specific responsibilities include: drafts SOPs within template, ensures that SOPs meet all applicable regulatory, financial, and legal requirements and are consistent with the practices of other departments; coordinates review of SOPs and revises documents; creates revision history for each SOP by analyzing changes in versions; ensures appropriate approval and distribution of SOPs; identifies document properties for entry in electronic document management system to allow for accurate retrieval of SOPs by users; managing and archiving SOP deviations; maintains common glossary, maintains archive of historical documents, and ensures SOPs are reviewed biannually. Participates with Compliance team in support of regulatory inspections. The incumbent will collaborate with other business partners for the development and maintenance of compliance processes in support of GCPs and applicable regulations pertaining to the Scientific Affairs COE and Op Co Medical Affairs processes. A minimum of a Bachelors degree required. A minimum of three years experience writing SOPs in a GXP environment required. A background in document management and technical writing highly preferred. Must have excellent English writing ability and fluency in spoken English. Knowledge of GCP, ICH regulations/requirements, and understanding of clinical trials desired. Experience with Microsoft Office, including Word, PowerPoint, and Excel is required. Candidate should have excellent interpersonal skills and be able to interact competently with personnel of different levels. Candidate should have basic project management skills. A quick learner with the ability to function independently is desired. Must work well with internal and external partners without formal authority. 5% travel required. If you want to explore the many small-company environments behind the big-company impact of the Johnson & Johnson Family of Companies, bid on this position today! Apply Now