Remote Medical Affairs Associate

Remote Medical Affairs Associate

13 Jun 2024
California, Santaclara, 95050 Santaclara USA

Remote Medical Affairs Associate

Vacancy expired!

Apex Systems is seeking a Medical Affairs Associate to join the team at one of our largest healthcare clients. This is a 6 month contract that has the possibility to extend.

For immediate consideration, please email a copy of your resume to Robbie Gosling at and reference Job ID #1154429.

Position Details:

Role: Medical Affairs Associate

Duration: 6 months Contract

Job Description:

Duties:
The Medical Affairs Associate is a key member of the Medical Affairs team. The candidate will be responsible for supporting the Medical Information Center and/or the Clinical Evaluation Reports (CER) process. The candidate is accountable for responding to both internal and external stakeholders across the globe, while observing and enforcing applicable local regulations (i.e., legal, regulatory, compliance) with flawless ethical conduct. Finally, the candidate will participate in cross-functional activities.

  • Assist with the creation and updates to the Clinical Evaluation Reports (CERs) to ensure timelines are met by collecting relevant documentation, participating in weekly calls with the medical writers, and helping coordinate review and approval of the CERs.
  • Coordinates and participates in Medical Information Center activities. Responds and coordinates responses to escalated requests. Assist in the generation review, and dissemination of medical letters for use by Medical Affairs field personnel. Participates in bi-weekly medical information center meetings.
  • Shares accountability with others for a positive team spirit that is characterized by mutual support, understanding, encouragement, and an active exchange of new ideas.
  • Ensures compliance with internal processes (SOPs and policies) and regulatory requirements and laws.
  • Assists Medical Reviewer in Copy Clearance process when requested.
  • Assists in generation/review of Company generated publications, and review of those related to clinical studies.
  • Conduct literature reviews and summaries of the literature as needed
  • Skills:
    Technical skills:
  • Operational processes, project/timeline management skills required
  • 1-3 years relevant Medical Affairs experience managing Clinical Evaluation Reports (CERs) and/or Medical Information or equivalent patient care experience and/or knowledge of cardiovascular procedures will be considered
  • Scientific/Research background (understanding research design, methodology, and statistics) preferred
  • Experience conducting scientific literature searches (PubMed, Embase, Cochrane, Google Scholar, etc.) and ability to identify relevant performance and safety data endpoints preferred
  • Familiarity with healthcare laws (e.g., HIPAA), ICMJE publication guidelines, and medical device regulations and guidance (e.g., 21 CFR 803/814/820, MDD 93/42/EEC, MDR 2017/745, MEDDEV 2.7.1 Rev 4, MEDDEV 2.12-2 Rev 2, etc.) preferred
  • Medical writing experience preferred

  • Personal skills:
  • Excellent oral and written communication skills to various audiences. Effective writing for various reports and customer responses with strong attention to detail
  • Maintain professional and scientific integrity
  • Strong work ethics and commitment to serve internal and external clients
  • Ability to prioritize and manage multiple projects
  • Open and honest approach to scientific debates and constant evaluation
  • Team player, " can-do " attitude
  • Ability and desire to develop good working internal and external relationships
    Other Skills:

    Computer skills (including personal computers, and business software, including PowerPoint, Excel, etc.) required.


  • 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

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