Business Analyst Jobs

Documentation Specialist

We are currently seeking a dedicated and meticulous Documentation Specialist to join one of our esteemed clients in the biopharmaceutical sector. At Fladger Associates, we understand that the right fit can lead to significant achievements, and we are committed to making this connection happen. If you have a keen eye for detail and a passion for maintaining accurate and organized documentation within a fast-paced environment, this role might be perfect for you.

Job Description

As a Documentation Specialist, you will play a crucial role in managing and overseeing the documentation processes within the organization. You will be responsible for ensuring that all documents are accurately maintained, updated, and compliant with regulatory standards. Your role will directly impact the efficacy and integrity of the company's operations, making you an integral part of the team. This position is ideal for those with experience as a clinical documentation specialist and looking to further their careers in a dynamic, growth-oriented environment.

Key Responsibilities

• Documentation Management: Oversee the creation, management, and maintenance of all company documentation, including manuals, guidelines, protocols, and reports.

• Compliance: Ensure all documentation complies with regulatory requirements and industry standards. Stay up to date with changes in regulatory guidelines and implement necessary adjustments.

• Quality Control: Perform regular audits and quality checks on documentation to ensure accuracy and completeness.

• Training and Support: Provide training and support to staff on documentation procedures and best practices. Serve as the go-to resource for any documentation-related queries.

• Process Improvement: Identify areas for improvement in documentation processes and implement effective solutions to enhance efficiency and accuracy.

• Collaboration: Work closely with various departments, including clinical, regulatory, and quality assurance, to ensure seamless documentation processes.

Qualifications

To thrive in this role, you should possess the following qualifications:

• Education: A bachelor's degree in Life Sciences, Clinical Research, or a related field is preferred.

• Experience: Minimum of 3-5 years of experience working as a clinical documentation specialist or in a similar role within the biopharmaceutical or related industry.

• Technical Skills: Proficiency in documentation management systems (DMS) and familiarity with regulatory documentation requirements.

• Attention to Detail: Exceptional attention to detail and the ability to identify discrepancies and errors in documentation.

• Communication Skills: Strong written and verbal communication skills. Ability to convey complex information clearly and concisely.

• Organizational Skills: Excellent organizational skills with the ability to effectively manage multiple tasks and deadlines.