Generating technical documentation in support of development and filing activities, as well as deficiency responses. Assignments are completed independently, escalating when appropriate.
Responsibilities/duties as described below extend from project start through approval.
Generates technical documentation such as API and Product Specifications, Analytical Procedures, Certificate of Analysis, and Technical Reports in support of filing activities and deficiency responses.
Documentation must be accurate, current, organized and consistent in format, style and content.
Review product specifications and analytical procedures, utilizing scientific understanding (USP,EP, etc.) for technical review of data as well as format.
Digests, comprehends, and reviews technical data; challenges submitted data for completeness, appropriateness, and suitability.
Review, edit, standardize, recommend, and coach scientists on appropriateness of submitted data.
Develop templates for technical documents such as: API and Product Specifications, Analytical Procedures (AP's) and Technical Reports (TR's).
Attends and participates in meetings/discussions with scientists and inter-departmentally to cooperatively establish milestones and deliverable dates.
Provides estimates on timing for generating technical reports based on workload.
Provides input on strategies to increase throughput time for generating and reviewing documentation.
Other duties as assigned by supervisor to support development and filing activities.
Bachelor Degree in Science field with major/focus in Chemistry.
Three years of previous technical document experience is required. Knowledge and adherence of industry standard technical writing practices required.
Knowledge/previous experience and understanding of scientific standards relating to creation of specifications and test results, filing procedures, template formats, and understanding of where appropriate information should be displayed in document for filing activities related to ANDA submissions required. Example: A Specialist II needs to have the knowledge as to when a forced degradation study was executed appropriately (in accordance with the associated protocol and procedures) and when the mass balance result meets the requirements.
Ability to manage multiple projects. Must be organized, detail/deadline-oriented, and possess the ability to adjust priorities to meet deadlines.
Excellent analytical, fact finding, interviewing, and problem solving skills.
Must possess excellent written communication skills; knowledge of structure and content of the English language (the meaning and spelling of words, rules of composition, and grammar, the ability to enter, transcribe, record, store, or maintain information in written or electronic form.
Must possess verbal communication skills; ability to communicate effectively, concisely, and in a collaborative manner with peers and management, ability to maintain a professional disposition which fosters open and honest dialog between coworkers, and the ability to manage and resolve differences.
Excellent computer skills (SME-like) and experience with MS Office applications (MS Word, MS Excel), Empower, LIMS system, Change Control applications (Trackwise, RECORD), and Electronic Documentation Archival Systems (Veeva Vault).
Solid knowledge of GMP requirements in a laboratory setting and thorough knowledge of scientific testing requirements.