Medical Writer I

LanceSoft Inc; Raritan (NJ); On-site; USD 80,000 - 100,000; Full time

Job summary

A leading healthcare consultancy in New Jersey is searching for a highly skilled individual to produce Product Risk Assessments for pharmaceutical products. Candidates should have at least five years of relevant experience, particularly in risk assessments of combination products and medical devices. Strong technical writing and project management skills are essential. Familiarity with the pharmaceutical industry, including knowledge of cGMPs, is mandatory. This role requires collaboration across various teams and proficiency in tools like Microsoft Office.

Qualifications

• Minimum of 5 years experience in pharmaceutical risk assessments.
• Proficiency in technical writing for manufacturing related activities is a must.
• Experience in Pharmaceutical manufacturing industry and regulatory requirements.

Responsibilities

• Write Product Risk Assessment documents for Pharmaceutical Products.
• Collaborate with medical, technical, manufacturing, and quality groups.
• Conduct risk analysis for pharmaceutical products.

Skills

Risk management methodologies

Technical writing

Project management

Documentation systems

Communication skills

Education

Bachelor's degree in Chemistry, Pharmacy or related field

MS/PhD/Pharm.D.

Tools

Microsoft Word

Microsoft Excel

Microsoft Visio

Microsoft Project

Job description

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.
• Ensure proper formatting, proof read, and route for approval in documentation system.
• Maintain and update project status in Microsoft Project, excel.

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

Key Decisions:

• 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

Project Management

Organization and Time Management

Communication (Verbal, Written, and Interpersonal)

Qualifications

Education/Experience Requirements:

• 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
• Prior experience managing projects is preferred

Additional Information

Job Description:

Write technical materials, such as SOP's, appendices

Duties and Responsibilities:

• Organize material and complete writing assignment according to set standards regarding order, clarity, conciseness, style, and terminology.
• Maintain records and files of work and revisions
• Edit, standardize, or make changes to material prepared by other writers or establishment personnel
• 2+ years experience as a Technical Writer
• 2+ years primary role writing user documentation for a variety of products, prepared as part of an integrated team