Quality Documentation Specialist

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 i s   clear, concise, and effective to global users.   Necessary Skills   and A bilities :   3+ years of e xperience 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…