202964 - Technical Writer
Industry
PRO
Region
OR-Oregon
City
Bend
State
OR
Rate
$30 to $35.00 DOE
Duration
3 Months
Description


Chipton-Ross is seeking a Technical Writer for a contract opportunity in Bend, OR.

SUMMARY:
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.

RESPONSIBILITIES:
1. Author high quality technical pharmaceutical development reports summarizing the experiments performed and conclusions made for the purpose of supporting regulatory submissions.
2. Maintain and continuously improve library of report templates.
3. Work directly with project team leads in multiple departments to collect and organize data for presentation.
4. 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.
5. 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.
6. Take responsibility for overall management of formulation development reports, including revisions, approval routing and timely status reporting to project teams and management.
7. 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.
8. Perform other document-related duties as assigned by management.

REQUIRED 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.
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.

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.

HARD REQUIREMENTS:
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.

EDUCATION:
Bachelor’s degree in physical science, engineering, or technical writing preferred.

WORK HOURS: Full-Time or Part-Time.

Employment will be contingent on clearing a drug screen and background check. Both must clear prior to start date.

Contact
Amy Shook
ashook@chiptonross.com
CHIPTON-ROSS, INC.
420 Culver Boulevard
Playa Del Rey, CA 90293

Phone: (310) 414-7800 x206 or (800) 927-9318 x206

Candidates responding to this posting must currently possess the eligibility to work in the United States. No third parties please.

Employment will be contingent on candidate clearing pre-employment drug screen and background check.

Chipton-Ross provides equal employment opportunities to all employees and applicants for employment without regard to race, color, creed, religion, national origin, sex (including pregnancy), age, disability, sexual orientation, gender identity and/or expression, protected veteran status, genetic information, or any other characteristic protected by Federal, State or local law. This policy governs all areas of employment at Chipton-Ross, including recruiting, hiring, training, assignment, promotions, compensation, benefits, discipline, and terminations.