Thermo Fisher Scientific Technical Writer II in Bend, Oregon
Authors solid oral dosage form pharmaceutical development reports based on data from formulation, process and analytical development experiments (e.g., tablet compression, spray drying, dry granulation, HPLC, GC, XRPD). Assimilates information and data from multiple sources, including the technical project leads and lead scientists assigned to the projects, to create seamless report deliverables that support regulatory submissions.
Authors high quality technical pharmaceutical development reports summarizing the experiments performed and conclusions made for the purpose of supporting regulatory submissions.
Maintains and continuously improves library of report templates.
Works directly with project team leads in multiple departments to collect and organize data for presentation.
Drafts & revises Standard Operating Procedures (SOPs) for the Formulation and Process Development (FPD) group in collaboration with FPD team members, FPD management, and other departments' personnel as appropriate to produce high quality, instructive documents.
Works with management to author deviations, change controls, and other documents as needed to support ongoing operations. Provides clear and high quality technical rationale for actions to be taken.
Takes responsibility for overall management of formulation development reports, including revisions, approval routing and timely status reporting to project teams and management.
Works with pharmaceutical scientists to observe operations in practice and uses knowledge gained to make master documents more user friendly and valuable to end users.
Other document-related duties as assigned by management.
Bachelor's degree in physical science, engineering, or technical writing preferred.
Two years of experience creating technical documents in an environment governed by document standards or protocols such as pharmaceutical, device, academia, healthcare or related field. Preferred Solid Oral Dosage manufacturing or analytical expertise.
Equivalent combinations of education, training, and relevant work experience may be considered.
Excellent technical writing, oral communication, collaboration and interpersonal skills are essential. Ability to manage client expectations in a professional manner is important. Knowledge of technical writing standards and protocols preferred. Familiarity with GMP, International Organization for Standardization (ISO) or equivalent standards is a plus. Familiarity with pharmaceutical equipment, processes, formulations, analytical techniques and Good Documentation Practices (GDP) desired. Must be highly proficient/advanced with Microsoft Word and an expert/fast typist. Skill with other Microsoft programs such as Excel, Visio, and PowerPoint are also valuable. Must be extremely detail oriented and organized. Ability to progress and track multiple projects simultaneously against tight deadlines with minimal oversight is important for success.
Position requires ordinary ambulatory skills and physical coordination sufficient to move about office and manufacturing locations; ability to stand, walk, stoop, kneel, crouch periodically for prolonged periods of time; manipulation (lift, carry, move) of light to medium weights of 10-35 pound pounds; arm, hand and finger dexterity, including ability to grasp and type for prolonged periods of time; visual acuity to use a keyboard, computer monitor, operate equipment, and read materials for prolonged periods of time; ability to sit, reach with hands and arms, talk, and hear for prolonged periods of time.
This job description is intended to present the general content and requirements for the performance of this job. The description is not to be construed as an exhaustive statement of duties, responsibilities, or requirements. Managers and supervisors may assign other duties as needed.
Nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees.
Please take note that we require a negative drug screen, administered by our third-party vendor, as a condition of employment.
Thermo Fisher Scientific is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, creed, religion, color, national or ethnic origin, citizenship, sex, sexual orientation, gender identity and expression, genetic information, veteran status, age or disability status.
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