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Principal Associate, Clinical Pharmacology Scientific Support & Reporting Writing

Principal Associate, Clinical Pharmacology Scientific Support & Reporting Writing

BioSpaceNorth Chicago, IL, United States
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Principal Associate, Clinical Pharmacology Scientific Support & Reporting Writing at BioSpace summary :

This role involves preparing and reviewing scientific reports related to clinical trials, contributing to protocol development, and ensuring the scientific integrity of clinical study data. The Principal Associate leads study development, applies advanced data analysis techniques, and supports multiple therapeutic areas within drug development. Responsibilities also include team leadership, process improvement, and presenting key clinical information to management.

Job Details

Company Description

AbbVie's mission is to discover and deliver innovative medicines and solutions that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas immunology, oncology, neuroscience, and eye care and products and services in our Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on X , Facebook , Instagram , YouTube , LinkedIn and Tik Tok .

Job Description

Purpose

To build all necessary data / information needed in preparing internal documents / scientific reports related to clinical trials and; to keep multiple reports moving forward simultaneously through multi-tasking.

Responsibilities

  • Prepare scientific reports / presentations related to clinical trials using available software and templates and; review / contribute to clinical protocols, by utilizing expertise, to assist in interpretation of data.
  • Assists in constructing phase 1 clinical study planning documents, and writes Phase 1 protocols.
  • Review clinical protocols and key decisions impacting project timelines with management.
  • Comply with procedures set forth in relevant IQS documents and Study protocols and other directives issued by the management regarding clinical studies.
  • Apply experience to analyze clinical study data, including statistical data using available software to assist with ongoing blinded / un-blinded PK, safety and efficacy reviews and ensure the scientific integrity of all processes.
  • Responsible for receiving and completing tasks and assignments from function, Therapeutic Area MD or Scientific Staff within timeline with minimal supervision and; maximizing individual, function / therapeutic area and team productivity.
  • Lead the study development by applying most current electronic document conventions / processes most consistently / accurately to ensure scientific integrity of all processes.
  • Participate on teams for process improvement initiatives and review key decisions impacting project timelines with management.
  • Perform literature / competitive intelligence searches to recognize / resolve scientific and technical problems by applying the most current electronic document conventions and processes consistently and accurately.
  • Provide / present key clinical study information to function / therapeutic area and management.

May lead teams within function / therapeutic area and supervise exempt and / or non-exempt direct reports and mentor function / therapeutic area personnel.

This is a hybrid opportunity that requires to be onsite 3x / week in Lake County, IL

Qualifications

Qualifications

  • Bachelors / Masters degree, in Science related to Field with 9+ years experience in the pharmaceutical industry or Pharm-D / PhD with 1+years
  • Ability to understand more complex clinical study principles
  • Advanced understanding of appropriate technology necessary to analyze clinical study data, generate reports and create presentations, posters and manuscripts
  • Experience in team, drug development, and scientific project leadership or related.
  • Experience supporting clinical research, drug development and / or function / therapeutic area operations.
  • Must have a proven record of successful projects.
  • Experience in multi-faceted, broad-based multiple functions / therapeutic areas or clinical functions with in depth knowledge of clinical study issues.
  • Ability to appropriately and effectively use resources to complete tasks and meet required timelines.
  • Ability to produce work of the highest quality by paying attention to detail
  • Must possess good oral and written communication skills
  • Additional Information

    Applicable only to applicants applying to a position in any location with pay disclosure requirements under state orlocal law :

  • The compensation range described below is the range of possible base pay compensation that the Companybelieves ingood faith it will pay for this role at the timeof this posting based on the job grade for this position.Individualcompensation paid within this range will depend on many factors including geographic location, andwemay ultimatelypay more or less than the posted range. This range may be modified in thefuture.
  • We offer a comprehensive package of benefits including paid time off (vacation, holidays, sick),medical / dental / visioninsurance and 401(k) to eligibleemployees.
  • This job is eligible to participate in our short-term incentiveprograms.
  • This job is eligible to participate in our long-term incentiveprograms
  • Note : No amount of payis considered to bewages or compensation until such amount is earned, vested, anddeterminable.The amount and availability of any bonus,commission, incentive, benefits, or any other form ofcompensation and benefitsthat are allocable to a particular employee remains in the Company's sole andabsolutediscretion unless and until paid andmay be modified at the Companys sole and absolute discretion, consistent withapplicable law.

    AbbVie is an equal opportunity employer and is committed to operating with integrity, driving innovation, transforming lives and serving our community. Equal Opportunity Employer / Veterans / Disabled.

    US & Puerto Rico only - to learn more, visit

    US & Puerto Rico applicants seeking a reasonable accommodation, click here to learn more :

    AbbVie's mission is to discover and deliver innovative medicines that solve serious health issues today and address the medical challenges of tomorrow. We strive to have a remarkable impact on people's lives across several key therapeutic areas : immunology, oncology, neuroscience, eye care, virology, women's health and gastroenterology, in addition to products and services across its Allergan Aesthetics portfolio. For more information about AbbVie, please visit us at . Follow @abbvie on Twitter , Facebook , Instagram , and YouTube .

    Stock Symbol : ABBV

    Stock Exchange : NYSE

    Company info

    Website Phone Location 1 North Waukegan Road

    North Chicago

    Illinois

    60064

    United States

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  • Keywords :

    clinical pharmacology, scientific reporting, clinical trials, drug development, protocol writing, data analysis, pharmaceutical research, therapeutic areas, study planning, team leadership

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