Medical Writer - Regulatory Affairs
Location: Indianola, PA (Hybrid)
Duration: 6-month contract (possibility of extension)
Target Pay Rate: $35-40.90/hr.
Position Summary:
We are seeking a detail-oriented Medical Writer (Expert) to join our Technical Publications Team at the Indianola, PA site. This role offers an initial 6-month contract with potential for extension. The ideal candidate will support the creation and revision of technical documents, including product labeling and operations manuals.
The Medical Writer will be involved in various technical writing projects, ensuring that product labeling complies with regulatory requirements and aligns with project timelines.
Key Responsibilities:
- Technical Content Creation: Gather and synthesize technical information to produce clear, concise, and compliant user instructions, standard operating procedures, and product labeling.
- Content Management: Utilize content management systems to develop, manage, and assemble technical documentation.
- Labeling Process Management: Oversee the setup, approval, verification, and release of product labeling within the Product Lifecycle Management (PLM) application.
- Collaboration & Compliance: Work closely with labeling specialists and strategists to ensure adherence to global regulatory requirements, offering guidance on labeling design and layout.
- Quality Assurance: Develop accurate product labeling and design control documentation, adhering to schedules to avoid delays in product launches while maintaining consistent branding and compliance standards.
Key Skills & Attributes for Success:
- Attention to Detail: Ability to focus on specifics while keeping the broader project goals in mind.
- Adaptability: Quickly learn and apply labeling requirements in a dynamic regulatory environment.
- Autonomy & Teamwork: Comfortable working independently and collaboratively within a team.
- Communication Skills: Excellent interpersonal and communication abilities to build strong relationships with cross-functional teams.
- Time Management: Proven ability to meet deadlines and manage multiple tasks effectively.
- Organization: Strong organizational skills to track labeling progress and communicate updates to project teams.
- Proactivity: Identifying and addressing potential labeling issues or discrepancies before they impact timelines.
Requirements:
- Experience: Minimum of 5 years in a regulated industry, with a focus on technical writing, labeling, or regulatory affairs.
- Education: Bachelor's degree in engineering, Science, Graphic Design, Professional/Technical Writing, or a related field.
- Technical Proficiency: Experience with Microsoft Office and technical software. Familiarity with content management systems is a plus.
- Tools & Software Experience: Experience with tools like Adobe FrameMaker, Adobe Illustrator, CorelDraw, or XML is desirable but not required.