[Hiring] Pharmacovigilance Medical Writing Manager @Med Communications International

Role Description

The Pharmacovigilance Medical Writing Manager 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

All work is conducted in accordance with applicable Good Clinical Practice requirements and legislation. The medical writer will work independently to review Client documents and author the reports, collaborating 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, leading by example, demonstrating agility, and navigating ambiguity are critical to success.
• 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 his/her 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 or following a systematic method of performing a task.
• Technical Aptitude - Ability to comprehend complex technical topics and specialized information.
• Financial Aptitude - Ability to understand and explain economic and accounting information, prepare and manage budgets.
• 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 in a way that makes the most of the learning experience.
• 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, regulatory submissions, pharmacovigilance reporting and medical communications.
• Pharmaceutical industry experience including an understanding and working knowledge of global legal, regulatory, and compliance requirements with regards to pharmacovigilance.

Company Description