[Hiring] Medical Writing Manager @Med Communications International

Role Description

The Medical Writing Manager (Pharmacovigilance) is responsible for writing and editing a variety of scientific and medical content, including but not limited to the following:

• Aggregate Reports
• Risk Management Plan (RMP)
• Risk Evaluation and Mitigation Strategies (REMS)
• Protocols
• Investigator brochures
• Clinical study reports
• Responses to regulatory questions
• Other clinical and regulatory documents

This role involves collaboration with the PV Project Leads and other relevant functions to ensure accuracy and clarity of all relevant content.

Qualifications

• Excellent working knowledge of relevant terminology, International Conference on Harmonization (ICH), Good Clinical Practice (GCP), Standard Operating Procedures (SOPs), applicable regulatory requirements, quality management processes.
• Superior writing and editorial skills, strong data analysis skills, ability to interpret clinical data and understand complex scientific and clinical information.
• Ability to contribute to, oversee and coordinate work of multiple PV staff members and vendor resources across multidisciplinary teams.
• Teamwork, communication, collaboration and alignment across a matrix organization are essential.
• Commitment to delivering high-quality timely results.
• Demonstrates innovative capacity and ability to implement change.
• Ethical - Ability to conform to a set of values and accepted standards.
• Accountability - Ability to accept responsibility and account for actions.
• Accuracy - Ability to perform work accurately and thoroughly.
• Analytical Skills - Ability to use thinking and reasoning to solve a problem.
• Detail Oriented - Ability to pay attention to the minute details of a project or task.
• Self Motivated - Ability to be internally inspired to perform a task to the best of one's ability.
• Organized - Possesses the trait of being well organized.
• Technical Aptitude - Ability to comprehend complex technical topics and specialized information.
• Financial Aptitude - Ability to understand and explain economic and accounting information.
• Tactful - Ability to show consideration for and maintain good relations with others.
• Problem Solving - Ability to find a solution for or to deal proactively with work-related problems.
• Active Listening - Ability to actively attend to, convey, and understand the comments and questions of others.
• Customer Oriented - Ability to take care of the client needs while following company procedures.
• Communication, Written - Ability to communicate in writing clearly and concisely.
• Communication, Oral - Ability to communicate effectively with others using the spoken word.
• Applied Learning - Ability to participate in needed learning activities.
• Demonstrated leadership skills.
• Excellent influencing and negotiation skills.
• Demonstrated ability to work in a matrix environment.
• Ability to establish and maintain effective working relationships with co-workers, managers and clients.
• Fluent in English.

Requirements

• 8-10 years of relevant experience including education and/or medical writing experience within pharmaceutical/biotech industry.
• Direct experience in the pharmaceutical/biotech industry with understanding of requirements for clinical trials and drug development.
• Pharmaceutical industry experience including an understanding and working knowledge of global legal, regulatory, and compliance requirements with regards to pharmacovigilance.

Company Description