Project Manager-Medical Writing in Bernards, NJ at Apex Life Sciences

Date Posted: 5/9/2018

Job Snapshot

Job Description


Project manager who has worked in the  medical writing world.

  • Overseeing and managing external writers; ensuring that processes are being followed; loading documents; and be involved with the mechanics of having documents completed. 
  • Organizes and leads meetings with study team members to determine timelines and processes for protocol and study report development. 
  • Provide independent document quality control services for documents on which the writer has no other role.
  • Organizing a project, taking a protocol, taking a protocol profile, review, approvals, QC, familiar with CST and CTDs (common technical document) format used for NDA
  • Check electronically published CSRs for completeness (appendices and required signatures present) and adherence to company’s electronic publishing standards before archiving.
  • Interacts with and supports CRO medical writers by communicating company standards, processes, templates, timelines, etc.

Experience

  • 5 years pharma experience (can be from a CRO) - mix of project management and medical writing
  • Must have held position as a project lead/manager.
  • Review documents; taking protocols; QC; nice to know common technical document (CTD) summary 
  • Use Veeva as the document management system; workflow system
  • Prefer oncology experience 
  • Medical writing experience required as the position may be responsible for hands-on writing, coordination of document reviews, and document quality control (QC) for documents produced by other writers. 
  • Documents must be of high quality in terms of scientific content, organization, clarity, accuracy, format and consistency, and adherence to regulatory requirements and company guidelines/styles/processes. 
  • Must be available to work onsite  (onsite 2-3 days/week), 
  • Prefer science degree: biology; biochemistry

To apply for this position please send resume or contact:

Vickie Dagit 

vdagit@apexlifesciences.com

919-334-0178

#LI-VD1

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, 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.

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, 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.