Lake Bluff, IL
We are currently searching for a skilled professional to join a well-known client’s team as a Medical Writer in Lake Bluff, Illinois. The purpose of this role is to ensure accurate and consistent coding of medical data including, but not limited to, adverse event verbatim descriptions and medication terms received from global clinical trials across all therapeutic areas. Their work will have a direct impact on not just the organization but the larger clinical industry making this an amazing career opportunity.
- Reviews safety-related data from clinical trials for content, quality, adherence to regulatory guidance and protocols
- Triages SAE information in order to fulfill timely reporting according to the authority and regulatory requirements
- Participates in applicable safety surveillance activities for assigned products
- Collects, analyzes, and triages AEs including reporting SAEs to IND safety
- Assessment of AE coding for consistency and accuracy of coding
- Medical review of safety-related CRFs and labs, including communication with Study Physicians
- Interface with study manager, CROs, CRAs, Data Management, PV to assure query resolution
- Creation of narratives of SAEs and other identified AEs of interest in accordance with accepted standards and with minimal revision required upon review
- A minimum of 5 years of experience required
- Pharma experience is required, TA is Oncology
- Broader knowledge of ICH and FDA regulations and guidelines affecting drug safety issues preferred Computer proficient (Windows, Word, Excel)
- Able to present adverse event data, orally and in writing
- RN required
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.