Job Description
Job Summary The Technical Writer will be responsible for creating, reviewing, revising, and finalizing high-quality documentation and labeling for the companies 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. The writer will also support departmental tools, processes, and corporate standards.
Key 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.
Qualifications/ Education Required: Bachelor's degree in a scientific discipline, business administration, or related technical field.
Equivalency: Equivalent combination of education and relevant experience may be substituted.
Experience Required: 5+ years of direct documentation experience in medical device, software, pharmaceutical, or biotechnology industries.
Required: Demonstrated knowledge of U.S. and international regulatory standards (FDA, ISO, IVDD, 21 CFR 11).
Required: Experience working on multiple projects within cross-functional teams.
Preferred: Experience with international regulatory requirements.
Technical Skills & Tools Required: Proficiency with Adobe Creative Cloud, desktop publishing tools, and online help authoring.
Required: Experience with SAP and Google Suite.
Preferred: Skills in illustration, graphics, and screen capture.
Required: Strong knowledge of word processors, spreadsheets, project management software, and electronic document management systems.
Soft Skills & Abilities 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.
Pay ranges between $24-28/hr based on experience
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.
Job Summary The Technical Writer will be responsible for creating, reviewing, revising, and finalizing high-quality documentation and labeling for the companies 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. The writer will also support departmental tools, processes, and corporate standards.
Key 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.
Qualifications/ Education Required: Bachelor's degree in a scientific discipline, business administration, or related technical field.
Equivalency: Equivalent combination of education and relevant experience may be substituted.
Experience Required: 5+ years of direct documentation experience in medical device, software, pharmaceutical, or biotechnology industries.
Required: Demonstrated knowledge of U.S. and international regulatory standards (FDA, ISO, IVDD, 21 CFR 11).
Required: Experience working on multiple projects within cross-functional teams.
Preferred: Experience with international regulatory requirements.
Technical Skills & Tools Required: Proficiency with Adobe Creative Cloud, desktop publishing tools, and online help authoring.
Required: Experience with SAP and Google Suite.
Preferred: Skills in illustration, graphics, and screen capture.
Required: Strong knowledge of word processors, spreadsheets, project management software, and electronic document management systems.
Soft Skills & Abilities 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.
Pay ranges between $24-28/hr based on experience
Equal Opportunity Employer: We are proud to be an equal opportunity employer. We welcome and encourage applications from all qualified candidates regardless of race, sex, gender identity or expression, disability, age, religion or belief, sexual orientation, or any other characteristic protected by applicable laws and regulations. It is our policy not to discriminate against any applicant or employee, and we are committed to fostering a diverse, inclusive, and respectful work environment across all locations in which we operate. We believe that diversity, equity, and inclusion are fundamental to our mission and enhance our ability to serve clients globally. If you have a disability or require any reasonable accommodations during the application or interview process, please inform your recruiter or contact us directly so that we can explore the appropriate arrangements.
Fraud Alert: Candidate safety is a top priority at Planet Pharma. The industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly, never provide banking information during the application process and always double check the email address of the Recruiter to ensure it's from an official Planet Pharma domain (@planet-pharma.com, @planet-pharma.co.uk, and @ppgadvisorypartners.com) and not a domain with an alternative extension like .net, .org or .jobs.