Apex is looking for a highly skilled REMOTE Medical Writing Project Manager! For immediate consideration, please send an updated resume to Nick, at Primary Writing and Technical Qualifications include Rev 4 CERs MDR CERs CEPs MDR and PMS plans Pay rate for qualified individuals 60.00-75.00+hour Job Profile and Summary 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 guidelinesregulations such as MEDDEV and MDDMDR is required. The Project Manager has the ability to lead cross-functional project teams. Essential duties and responsibilities Develop and manage PMS and CER project plans, timelines, and project tracking tools. Write PMS plans using 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 periodic reviews of risk documentation, product labeling, and marketing brochures as part of the clinical evaluation process. Participate in andor 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. Consistently apply applicable global regulations and guidelines Manage contract writers Maintain contractor agreements, CVs, and training records Maintain and update spreadsheets tracking the status for PMS Plans and CER projects Work with the manager to schedule meetings and keep track of the progress and outcomes of the projects. Work closely with Directors, managers and medical writers to schedule meetings to kick off new projects, update changes with team on the projects. 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. Accountable for maintaining project activity tracking through meetings and associated tracking spreadsheet. Responsible for collecting, maintaining, archiving and retrieving all documents necessary to ensure compliance with SOP Technical skills Bachelors or above science healthcare degree preferred and 3-5 years related medical device experience Excellent written communication skills Experience writing CERs andor PMS plans Experience in project management is required Demonstrated high level of personal integrity, emotional intelligence, flexibility Understanding of the legal and regulatory environment Clinical background, or extensive clinical research experience in the device or pharmaceutical industry Extensive knowledge of MDD, MDR and MEDDEV regulations and guidance Experience with Microsoft applications Education Advanced degree in sciencehealthcare field preferred and 3-5 years related medical device experience EEO Employer Apex Systems is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at or .
Posting ID: 600967797Posted: 2021-01-21