Technical Writer (GMP)

Yoh Services LLC; Maryland Heights (MO); On-site; USD 41,328 - 50,971; Full time

Benefits offered by this job

Medical, Prescription, Dental & Vision Benefits

401K Retirement Savings Plan

Referral Bonus Programs

Job summary

Yoh Services LLC is hiring a Technical Writer (GMP) for a pharmaceutical manufacturing client in St. Louis, Missouri. The role focuses on maintaining compliance with regulatory agencies and managing project submissions.

Ideal candidates will have a Bachelor’s degree in a technical field and 3+ years of Regulatory Affairs support experience. The position offers competitive compensation and comprehensive benefits for employees working 20+ hours per week.

Qualifications

• 3+ years Regulatory Affairs support in submission content or publishing.
• 3+ years Project Management experience in Pharmaceutical or Health related industry.
• Ability to manage multiple, conflicting priorities.

Responsibilities

• Maintain operational compliance with regulatory agencies.
• Manage project submissions and key projects for approval and launch.
• Collaborate with RA staff to mitigate resource conflicts.

Skills

Regulatory Affairs knowledge

Project Management

Communication skills

Education

Bachelor’s Degree in technical discipline

Job description

Technical Writer (GMP) – Pharmaceutical Manufacturing – St. Louis, Missouri

Yoh is hiring a Technical Writer (GMP) for our Pharmaceutical Manufacturing client in St. Louis, Missouri.

Essential Job Functions

• Maintain operational compliance with US and international regulatory agencies and guidelines (i.e. FDA, DEA, EU, HC, TGA, RIC/S, ISO, USP, NRC, cGMP, etc.)
• Manage project submissions as assigned by Director Regulatory Affairs including department work process.
• Manage key projects, planning, timing, and execution for submission, approval, and launch.
• Maintain project database for tracking individual and department project deliverables.
• Manage incoming requests through logging, assigning, tracking, working with RA staff to manage complexity and difficulty, and maintain department metrics.
• Maintain database and tracking of key department deliverables.
• Facilitate use of regulatory electronic submission software to allow more efficient compilation process.
• Collaborate with RA staff assigned to projects in order to prospectively mitigate RA resource conflicts.
• Manage multiple, sometimes conflicting priorities.
• Maintain and track deliverables.

Education & Experience Requirements

• Bachelor’s Degree in technical discipline, pharmaceutical industry, or related life science preferred.
• Project Management Experience – Certification Preferred.
• 3 or more years Regulatory Affairs support of submission content, compilation, or publishing.
• 3 or more years Project Management experience in Pharmaceutical or Health related industry.
• Ability to facilitate decision making; specific content expertise may reside with team members.
• Experience in Project set-up/initiation, executions, and completion within established timeframes.

Compensation

Estimated Min Rate: $30.00

Estimated Max Rate: $37.00

Benefits

Benefit eligibility is in accordance with applicable laws and client requirements. Benefits include:

• Medical, Prescription, Dental & Vision Benefits (for employees working 20+ hours per week)
• Health Savings Account (HSA) (for employees working 20+ hours per week)
• Life & Disability Insurance (for employees working 20+ hours per week)
• MetLife Voluntary Benefits
• Employee Assistance Program (EAP)
• 401K Retirement Savings Plan
• Direct Deposit & weekly ePayroll
• Referral Bonus Programs
• Certification and training opportunities

Note: Any pay ranges displayed are estimates. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https://www.yoh.com/applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.

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