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Medical Writing Project Manager - Remote
at Apex Systems, Inc.
Mansfield, MA

Medical Writing Project Manager - Remote
at Apex Systems, Inc.
Mansfield, MA

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Description

Apex is seeking a Remote Medical Writing Project Manager who will be responsible for the planning and development of Clinical Evaluation Reports to support Medical Solutions devices.

Responsibilities:

  • Develop and manage Clinical Evaluation Report (CER) project plans, timelines, and project tracking tools.
  • 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 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.
  • Consistently apply applicable global regulations and guidelines, as well as internal policies and procedures
  • Manage contract writers
  • Maintain contractor agreements, CVs, and training records
  • Maintain and update spreadsheets tracking the status for CER projects
  • Work with the manager to schedule meetings and keep track of the progress and outcomes of the projects.
  • Work closely with Sr. 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
  • May help develop/write reports

Qualifications:

  • Bachelors or above science / healthcare degree preferred and 3-5 years related medical device experience required; Advanced degree in science/healthcare field preferred
  • Excellent written communication skills
  • Experience in project management is required
  • Ability to understand and effectively communicate scientific information; respond to inquiries and address needs of key stakeholders
  • Demonstrated ability to build positive constructive relationships with cross-functional team members
  • Demonstrated high level of personal integrity, emotional intelligence, flexibility
  • Understanding of the highly regulated medical device industry environment
  • 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 guidances
  • Strong work ethic and commitment to serve internal and external clients
  • Proactive with a sense of urgency in managing job responsibilities
  • Attention to detail
  • Energy, focus, motivation and debate-friendly
  • Analytical thinking and inquisitive mindset for investigations and problem solving
  • Team player, “can-do” attitude and excellent interpersonal skills
  • Ability and desire to develop good working relationships internally and externally
  • Ability to work with a minimum of supervision.
  • Ability to work in a team environment.

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 employeeservices@apexsystemsinc.com or 844-463-6178.


VEVRAA Federal Contractor
We request Priority Protected Veteran & Disabled Referrals for all of our locations within the state.
We are an equal opportunity employer. We evaluate qualified applicants without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, veteran status, or any other protected characteristic. The EEO is the Law poster is available here.

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