Medical Writer I

The applicant will write Product Risk Assessment documents for Pharmaceutical Products and require specific experience in Risk assessments of combination products and/or medical devices. The applicant should have experience using risk management methodologies, tools, incorporate appropriate data and information, and conduct risk calculations.

The applicant must understand pharmaceutical and/or device manufacturing processes, design controls, and be able to lead and conduct FMEAs. Specific experience with user/design/process FMEAs for medical devices is desirable. A minimum of Five (5) years experience is required.

The applicant should be proficient in Microsoft Word, Excel, Visio, Microsoft Project and have experience with documentation systems. The applicant must have experience in leading and facilitating teams to finalize reports with approvals per standard operating procedures.

The incumbent will work with medical, technical, manufacturing, and quality groups to develop Product Risk Assessments by conducting risk analysis for pharmaceutical products. Job Responsibilities include:

• Collate appropriate and pre-populating the document based on product information, patient/user information, and other supporting documents.

(the incumbent should have the ability to search these documents, understand the process and extract required information)

• Ensure proper formatting, proof read, and route for approval in documentation system.

• Maintain and update project status in Microsoft Project, excel.

• Participates in decisions and provides input and prepares product risk management reports regarding the adequacy, accuracy, interpretation, and clarity, and final decisions made by the project team.

• Consults with appropriate groups (as required) regarding the acceptability of documentation

• Bachelor's degree in Chemistry, Pharmacy or a related science field plus 4-6 years of relevant experience industrial experience in the healthcare industry

• OR MS/PhD/Pharm.D. plus 3-4 years of pharmaceutical industrial experience

• Minimum of 1-2 years of technical writing experience for manufacturing related activities is mandatory

• Experience working in the Pharmaceutical manufacturing industry (preferably in Technical Services, Operations, manufacturing plant or Research & Development or QA, knowledge of pharmaceutical development processes, cGMPs and regulatory requirements are required.

• Excellent English, writing and oral presentation skills is mandatory

• Prior experience with Pharmaceutical Industry is mandatory

• Organize material and complete writing assignment according to set standards regarding order, clarity, conciseness, style, and terminology.

• Edit, standardize, or make changes to material prepared by other writers or establishment personnel

• 2+ years primary role writing user documentation for a variety of products, prepared as part of an integrated team