Medical Writer

Princeton, NJ

Contract

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OVERVIEW

We are currently searching for a skilled professional to join a well-known client’s team as Medical Writer in Princeton, New Jersey.  The Medical Writer role will focus on exceptional clinical writing in the pharmaceutical industry, and they will use their knowledge of regulatory guidelines to create and oversee all clinical documents, including regulatory submission requirements and processes. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity!

RESPONSIBILITIES

  • Prepare both the methods and results sections of clinical study documents
  • Handle regulatory submission requirements and processes
  • Follow Standard Operating Procedures (SOPs) in all clinical writing functions
  • Perform standard Quality Control functions in the clinical writing group (e.g., quality check in-text tables against statistical tables, verify titles in standard table of contents, paginate a document, etc.) 
  • Coordinate project-related administrative tasks 
  • Utilize the constructing tables, graphs, and figures features within Microsoft Word to finalize documents 

EXPERIENCE

  • Experience/training is required in the following areas: Applicable Standard Operating Procedures,
  • Good Clinical Practices (i.e. GxP Regulations; ICH Guidelines; Good Quality Practices),
  • 21 CFR Part 11 and Computer Security (Part 11, Electronic Records; Electronic Signatures-Scope and Application; 21 CFR 11 and Industry Guidance; Computerized Systems Used in Clinical Trials), HIPAA, Drug Development, and Approval Process

EDUCATION

  • Bachelor’s Degree required in life sciences or a closely related field

To be a best-fit your strengths must include

  • Strong Communicator. You will have extensive correspondence that relies on you being conversant in regulatory guidelines and clinical terminology. 
  • Organized. You’re an efficient time-manager and can handle the pressure of meeting multiple strict deadlines. 
  • Ability to work independently and with a team: You will be collaborating and often contributing to discussions amongst internal teams; you also work effectively without a lot of support or structure. 
  • Problem-Solvers.  As an action-oriented self-starter, you’re eager to apply your expertise in diagnosing inefficiencies, determining root causes, and recommending solutions to complex challenges.
  • Personable. You establish and nurture highly effective relationships with colleagues and key stakeholders that support and advance project goals and objectives.   
  • Credible. Thorough understanding of clinical methodologies and providing sound analytical support, you quickly establish credibility as a reliable resource.  

About Advanced Clinical

Advanced Clinical is an award-winning clinical development organization that provides global services including CRO, Functional Support, Quality & Validation, Patient Recruitment and Retention, and Strategic Talent Acquisition solutions for pharmaceutical, biopharmaceutical, biotechnology, and medical device organizations. Our mission is to deliver a truly better clinical experience for our clients and candidates. To learn more about Advanced Clinical which has been named to Chicago Tribune’s Top Workplaces, Chicago’s Best and Brightest Companies, and Best of Staffing Talent & Client, visit http://www.advancedclinical.com.

Regarding your application

Please know that every completed application is carefully reviewed by the Advanced Clinical recruitment team. We understand the time commitment that is needed to prepare an application, so we respect your effort by thoughtfully reviewing and responding to each application. In return, we ask for your patience as careful review takes time, and we may not be able to respond to every application immediately.

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