Medical Writing Project Manager

The Medical Writing Project Manager is a member of the Medical Affairs team, within in Global Medical Products, and is responsible for the planning, development, writing and reviewing Post Market Surveillance Plans and Clinical Evaluation Reports for the medical devices.

The Project Manager has medical writing experience, strong project management expertise, a thorough understanding of research methodology and the ability to develop high-quality clinical documents.  Extensive knowledge of the European medical device guidelines/regulations such as MEDDEV and MDD/MDR is required. The Project Manager has the ability to lead cross-functional project teams.

Responsibilities

• Develop and manage PMS and CER project plans, timelines, and project tracking tools.
• Manage contract writers including maintaining contractor agreements, CVs, training records, ensuing timelines are adhered to and providing feedback on the prepared documents.
• Write PMS plans using the analysis done in the CER.
• Plan and deliver intra-departmental and cross-functional communication to ensure critical information is transmitted to relevant parties in a timely manner.
• Perform comprehensive literature searches to develop and maintain in-depth knowledge and understanding of current scientific literature and state of the art to support assigned product lines.
• Apply applicable global regulations and guidelines, as well as Cardinal Health policies and procedures.
• Collect, maintain, archive and retrieve all documents necessary to ensure compliance with SOPs and regulations.
• Participate in audits.

Qualifications

• Bachelors in a relevant discipline required. Master's degree or PhD highly preferred.
• 3-5 years related medical device experience preferred.
• Clinical background, or extensive clinical research experience in medical device or pharmaceutical industry.
• Experience writing CERs and/or PMS plans in accordance with Meddev 2.12.2 and MDR.
• Excellent written communication skills.
• Experience managing medical writing projects.
• Ability to understand and effectively communicate scientific information; respond to inquiries and address needs of key stakeholders and auditors.
• Demonstrated high level of personal integrity, emotional intelligence, flexibility.
• Experience creating and performing literature searches in Embase, PubMed and Google Scholar.
• Experience using Microsoft Word, Excel, PowerPoint.
• Analytical thinking and inquisitive mindset.
• Ability and desire to develop good working relationships internally and externally.

Experience

• Applies advanced knowledge and understanding of concepts, principles, and technical capabilities to manage a wide variety of projects.
• Participates in the development of policies and procedures to achieve specific goals.
• Recommends new practices, processes, metrics, or models.
• Works on or may lead complex projects of large scope.
• Projects may have significant and long-term impact.
• Provides solutions which may set precedent.
• Independently determines method for completion of new projects.
• Receives guidance on overall project objectives.
• Acts as a mentor to less experienced colleagues.