The Medical Writing Project Manager is a member of the Medical Solutions Medical Affairs team and is responsible for the planning, development, writing and reviewing Post Market Surveillance Plans and Clinical Evaluation Reports to support Medical Solutions devices. Primary responsibilities include managing and writing Post Market Surveillance (PMS) Plans and Clinical Evaluation Reports (CERs) according to established procedures. Additional responsibilities may be assigned.
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.
Essential duties and responsibilities:
1. Develop and manage PMS and CER project plans, timelines, and project tracking tools.
2. Write PMS plans using analysis done in the CER
3. Plan and deliver intra-departmental and cross-functional communication to ensure critical information is transmitted to relevant parties in a timely manner.
4. Perform periodic reviews of risk documentation, product labeling, and marketing brochures as part of the clinical evaluation process.
5. Participate in and/or 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.
6. Consistently apply applicable global regulations and guidelines, as well as client policies and procedures
7. Manage contract writers
8. Maintain contractor agreements, CVs, and training records
9. Maintain and update spreadsheets tracking the status for PMS Plans and CER projects
10. Work with the manager to schedule meetings and keep track of the progress and outcomes of the projects.
11. Work closely with Directors, managers and medical writers to schedule meetings to kick off new projects, update changes with team on the projects.
12. Responsible for the coordination of projects by following established SOPs. Collaborate with other key stakeholders to ensure that projects are coordinated and tracked in a standardized way.
13. Accountable for maintaining project activity tracking through meetings and associated tracking spreadsheet.
14. Responsible for collecting, maintaining, archiving and retrieving all documents necessary to ensure compliance with SOP
1. Bachelors or above science / healthcare degree preferred and 3-5 years related medical device experience
2. Excellent written communication skills
3. Experience writing CERs and/or PMS plans
4. Experience in project management is required
5. Ability to understand and effectively communicate scientific information; respond to inquiries and address needs of key stakeholders
6. Demonstrated ability to build positive constructive relationships with cross-functional team members
7. Demonstrated high level of personal integrity, emotional intelligence, flexibility
8. Understanding of the highly regulated medical device industry environment
9. Understanding of the legal and regulatory environment
10. Clinical background, or extensive clinical research experience in the device or pharmaceutical industry
11. Extensive knowledge of MDD, MDR and MEDDEV regulations and guidances
12. Experience with Microsoft applications
1. Strong work ethic and commitment to serve internal and external clients
2. Proactive with a sense of urgency in managing job responsibilities
3. Attention to detail
4. Energy, focus, motivation and debate-friendly
5. Analytical thinking and inquisitive mindset for investigations and problem solving
6. Team player, “can-do” attitude and excellent interpersonal skills
7. Ability and desire to develop good working relationships internally and externally
Advanced degree in science/healthcare field preferred and 3-5 years related medical device experience
Ability to work with a minimum of supervision.
Ability to work in a team environment.