Quality Documentation Specialist
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What you'll do
- Manage the controlled document approval process (author, review, approval).
- Assist project teams in updating global and local controlled documents.
- Manage high volume of document updates from multiple regions and projects.
- Identify the procedures that need to be updated due to planned process changes.
- Coordinate procedure editing and review activities across global sites.
- Assist document authors with alternative wording, presentation, and style to ensure clarity of content.
- Assist project teams with harmonizing document update feedback from multiple reviewers.
- Edit draft procedural documents to ensure the technical material is clear, concise, and effective to global users.
What they're looking for
- 3+ years of experience in technical writing, specializing in Standard Operating Procedures (SOPs) and Work Instructions for the Pharmaceutical industry.
- 3+ years of experience processing documents through the entire document life cycle, including Change Requests, red-lining, stakeholder review, submission for approvals, and retirement
- Excellent written and spoken English.
- Experience using electronic document management systems
- Highly proficient in MS Office products, such as Word, PowerPoint, and Excel.
- Expertise in SOP writing techniques.
- Ability to work effectively with remote team members across different time zones.
- Able to work flexible hours when needed to accommodate global project teams.
- Able to work effectively with other professionals, such as Quality Assurance specialists, pharmacovigilance specialists, and information technology specialists.
- Ability to work independently with minimal supervision.
- Ability to work on multiple simultaneous projects with tight deadlines.
- Excellent organizational skills and attention to detail.
Nice to have
- Veeva experience is a plus.
- Basic knowledge of GMP, GCP, and GPvP processes is a plus.
Summarised by NextRaise from the employer’s description, which follows in full below.
Full description from employer
For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.
This Technical Procedure Writer position within Quality and Compliance is responsible for supporting clients’ development, updates, reviews, and approvals of Quality Documents, such as Policies, Procedures, and Work Instructions.
Essential Functions:
Manage the controlled document approval process (author, review, approval).
Assist project teams in updating global and local controlled documents.
Manage high volume of document updates from multiple regions and projects.
Identify the procedures that need to be updated due to planned process changes.
Coordinate procedure editing and review activities across global sites.
Assist document authors with alternative wording, presentation, and style to ensure clarity of content.
Assist project teams with harmonizing document update feedback from multiple reviewers.
Edit draft procedural documents to ensure the technical material is clear, concise, and effective to global users.
Necessary Skills and Abilities:
3+ years of experience in technical writing, specializing in Standard Operating Procedures (SOPs) and Work Instructions for the Pharmaceutical industry.
3+ years of experience processing documents through the entire document life cycle, including Change Requests, red-lining, stakeholder review, submission for approvals, and retirement
Excellent written and spoken English.
Experience using electronic document management systems; Veeva experience is a plus.
Highly proficient in MS Office products, such as Word, PowerPoint, and Excel.
Expertise in SOP writing techniques.
Ability to work effectively with remote team members across different time zones.
Able to work flexible hours when needed to accommodate global project teams.
Able to work effectively with other professionals, such as Quality Assurance specialists, pharmacovigilance specialists, and information technology specialists.
Ability to work independently with minimal supervision.
Ability to work on multiple simultaneous projects with tight deadlines.
Excellent organizational skills and attention to detail.
Educational Requirements:
AS or BS degree in a related field.
Experience Requirements:
3+ years of experience in technical writing, specializing in Standard Operating Procedures (SOPs) and Work Instructions for the Pharmaceutical industry, including:
Experience with the entire documentation development life cycle from procedure design, authoring, and approval workflow management.
Basic knowledge of GMP, GCP, and GPvP processes is a plus.
We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.
All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us - whether you're successful or not.
Whilst ProPharma supports remote working, we also recognise the value that comes from in person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office.
***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***
Company
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