Planet Pharma · 14 hours ago
Technical Writer - PHCS
Planet Pharma is seeking a Technical Writer responsible for creating, reviewing, revising, and finalizing high-quality documentation for the company's products. This role serves as a key point of contact between project teams and the Technical Documentation Department, ensuring timely delivery of compliant documentation in alignment with project schedules and regulatory standards.
BiotechnologyHealth CarePharmaceutical
Responsibilities
Act as primary Technical Writer on cross-functional project teams, attending meetings, tracking schedules, and reporting updates to the Documentation Supervisor
Develop, edit, and maintain clear, accurate, and compliant documentation and labeling for product design, manufacturing, testing, release, installation, and distribution
Facilitate the documentation review and approval process, resolving resource or timeline conflicts as needed
Serve as liaison between project leaders and the Technical Documentation Department, conducting formal meetings and ensuring clear communication
Use desktop publishing tools and Adobe Creative Cloud to produce professional text and graphics
Assist in maintaining translated documents, corporate standards, and certificate library management
Ensure compliance with quality system regulations (FDA, ISO, IVDD, 21 CFR 11) and support internal/external audits
Maintain and improve documentation tools, processes, and performance metrics
Collaborate effectively with interdepartmental teams, vendors, and customers
Perform other duties as assigned by management
Qualification
Required
Bachelor's degree in a scientific discipline, business administration, or related technical field
5+ years of direct documentation experience in medical device, software, pharmaceutical, or biotechnology industries
Demonstrated knowledge of U.S. and international regulatory standards (FDA, ISO, IVDD, 21 CFR 11)
Experience working on multiple projects within cross-functional teams
Proficiency with Adobe Creative Cloud, desktop publishing tools, and online help authoring
Experience with SAP and Google Suite
Strong knowledge of word processors, spreadsheets, project management software, and electronic document management systems
Excellent written and verbal communication skills
Strong organizational, negotiation, and problem-solving abilities
Ability to work independently, manage multiple priorities, and meet deadlines
High attention to detail and commitment to quality
Ability to present information clearly to diverse audiences
Preferred
Experience with international regulatory requirements
Skills in illustration, graphics, and screen capture
Company
Planet Pharma
Planet Pharma is a pharmaceuticals company.
H1B Sponsorship
Planet Pharma has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2022 (3)
2021 (5)
2020 (5)
Funding
Current Stage
Late StageLeadership Team
Company data provided by crunchbase