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Job Details



Medical Information Writer  RTP, NC  Posted: 5/9/2022
Job Description

Job ID#:

7092


Alphanumeric is hiring a Remote Medical Writer to work on writing assignments for one of the largest pharmaceutical companies in the world. 
Remote Locations: NC and PA
Great global Pharma opportunity!
 
This position is remote for Health Care Provider (HCP) holding a PharmD, BSN, MD or RPh having 2- 5 years of medical information writing experience across multiple therapeutic areas with preference in Oncology and Immunology.
 
Responsibilities:
  • Collaborate with members of cross functional teams to prepare, update and create content and researching information for protocols, investigator brochures, synopses, regulatory documents, clinical publications, and related clinical documents within agreed-upon timelines.
  • Prepares, edits, and finalizes MI Letters, Standard Operating Procedures, Investigator Brochures, Post Marketing Safety Reports, Presentations, Posters, Clinical trial information, Trial Summaries, and Patient Communications
  • Schedules and conducts document-related meetings including the preparation of pre-meeting agenda, key data points for discussion, and post-meeting minutes
  • Collaborates with clinicians, clinical scientists, and others to interpret study results and ensure study results and statistical interpretations are accurately and clearly reflected in relevant documents
  • Participates in scientific communication planning, including development of strategic medical communication plans
  • Manages the document review process ensuring conflicting and/or ambiguous comments are clarified and appropriately addressed
  • Works closely with the study team to ensure that results and messages in clinical documents accurately reflect the data in information sources.
  • Completes documents according to agreed-upon timelines and follows up with the study team as needed to meet internal and external timeline commitments, and to ensure SOP and regulatory compliance
  • Understands the functions and roles within the study team and aligns with them in delivery of documents to meet project-related goals and to meet external results disclosure obligations
  • Creates and maintains standard operating procedures and work instructions for preparation and maintenance of compliant medical writing deliverables
  • Ensures documents are generated in accordance with agreed internal processes and standards, are submission ready, and are appropriately stored in agreed document management system
  • Ensures that appropriate documented quality control (QC) checks are performed on medical writing deliverables, responds to findings, and recommends quality process improvements
  • Ensures that medical writing deliverables conform to relevant regulatory guidelines
  • Suggests or identifies changes, modifications, and improvements to the document preparation processes and templates in order to improve quality, efficiency, and productivity
  • Align with department management to set strategy for meeting department goals

 
Job Requirements

 

Requirements
  • PharmD, BSN, or RPh
  • 2-5 years of relevant Medical information writing experience preferably in Immunology and Oncology
  • Broad experience managing the medical writing responsibilities associated with multiple studies at various stages
  • Experience with MSL Slide Decks and Infographics is needed for this position. 
  • Knowledge of clinical research concepts, practices, and FDA regulations and Guidelines regarding drug development phases, clinical research and medical writing standards; demonstrated ability to interpret and apply these guidelines to document writing
  • Experience in interacting with cross functional study team members
  • Ability to communicate with teams to set realistic timeline expectations; demonstrated ability to deliver within agreed internal and regulatory timelines; monitor and communicate progress against milestones; escalate complex issues appropriately.
  • Excellent interpersonal, active listening, and influencing skills; establishes and maintains professional and productive working relationships with team members
  • Proficiency in Word, Excel, PowerPoint, Outlook
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