Technical Writer

Overview:

TekWissen Group is a workforce management provider throughout the USA and many other countries in the world. The below job opportunity is to one of Our clients who offer biotechnology product development services. The Company focuses on providing laboratory equipment, chemicals, supplies and services used in healthcare, scientific research, safety, and education.

Job Title: Technical Writer

Duration: 3 Months

Work Location: Bend OR 97701

Job type: Contract

Work type: Onsite

Job Description:

How will you make an impact?

• The Technical Writer 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).

• They assimilate 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.

What will you do?

• Author high quality technical pharmaceutical development reports summarizing the experiments performed and conclusions made for the purpose of supporting regulatory submissions.

• Maintain and continuously improve library of report templates.

• Work directly with project team leads in multiple departments to collect and organize data for presentation.

• Draft & revise 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.

• Work with management to author deviations, change controls, and other documents as needed to support ongoing operations. Provide clear and high quality technical rationale for actions to be taken.

• Take responsibility for overall management of formulation development reports, including revisions, approval routing and timely status reporting to project teams and management.

• Work with pharmaceutical scientists to observe operations in practice and uses knowledge gained to make master documents more user friendly and valuable to end users.

• Perform other document-related duties as assigned by management.

How will you get here?

Education

• Bachelor's degree in physical science, engineering, or technical writing preferred.

Experience:

• 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.

Equivalency:

• Equivalent combinations of education, training, and relevant work experience may be considered.

Competencies:

• 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.

Physical Requirements:

• 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.

TekWissen Group is an equal opportunity/affirmative action Employer (m/f/d/v) supporting workforce diversity