Senior Medical Writer (Remote)

Company: AbbVie
Location: Waterloo
Posted on: March 20, 2023

Job Description:

The Senior Medical Writer is responsible for providing scientific publications or clinical regulatory document support to the clinical teams, ensuring successful preparation of high quality submission-ready documents and effective implementation of the clinical writing process. Provides medical writing expertise for multiple compounds and/or projects within a therapeutic area. Interfaces with external groups (e.g., PK, Toxicology, eSubmissions, Regulatory, Statistical Support, Data Management, Clinical, Publishing) to ensure accurate and timely completion/delivery of information and review of scientific publications or clinical regulatory submissions.

• Serves as medical writing lead on scientific publications or clinical regulatory documents. Implements all activities related to the preparation of scientific publications (e.g. abstracts, posters/oral presentations, manuscripts) or to the preparation and compilation of data and information into a single comprehensive package for new and updated clinical regulatory documents (US and ex-US).
• Serves as a department representative on project teams. Acts as Subject Matter Expert for assigned clinical teams regarding computer-based technologies utilized by the respective departments (e.g, COSMOS, eCTD, journal/congress databases). May mentor and provide guidance to more junior medical writers. Implements tactical process improvements.
• Converts relevant data and information into a form that meets clinical regulatory document requirements. Explains data in manner consistent with the target audience(s), journal/congress requirements, and/or clinical regulatory requirements. Coordinates the review, approval, and other appropriate functions involved in the production of scientific publishing or clinical regulatory projects. Arranges and conducts review meetings with the team. Ensures required documentation is completed.
• Knowledgeable of US and international regulations, requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions. Learns and applies knowledge of therapeutic area and product to scientific publishing projects. Must continually train/be compliant with all current industry requirements as they relate to scientific publications or clinical regulatory submissions, including electronic submission/approval standards.
• Effectively communicates clinical regulatory document deliverables needed, writing process, and timelines to team members. Holds team members accountable to agreed-upon project dates. Negotiates with functional areas on project outcomes and deliverables to meet conflicting demands. Identifies and proposes solutions to resolve issues and questions arising during the writing process, including resolution or elevation as appropriate.
• Understands, assimilates, and interprets sources of information with appropriate guidance/direction. Interprets and explains data generated from a variety of sources. Challenges conclusions when necessary. Able to independently resolves most document content issues and questions. Understands/complies with appropriate conventions, proper grammar usage, and correct format requirements per journal/congress, ICH and other governing bodies following applicable divisional guidelines, templates, and SOPs.
• Arranges and conducts review meetings with the team. Acts as interface to resolve issues and questions arising during the writing process. Works with Regulatory Quality Assurance throughout clinical regulatory document audit process, answers questions during the audit process (as appropriate), and works with team to draft responses as necessary.
• Recommends and implements tactical process improvements.Requirements
  • Bachelor's degree in English or Communications with relevant science expertise or Bachelor'sdegree in Life Science with relevant writing expertise.
  • 2-3 years relevant industry experience in medical writing in the healthcare industry or academia required or in a related area such as quality, regulatory, clinical research, or product support/R&D.
  • American Medical Writing Association (AMWA) certification or other is preferred, with a specialty in Editing/Writing or Pharmaceutical.
  • Ability to assimilate and interpret scientific content and translate information for appropriate audiences.
  • Excellent written and oral communication skills. Knowledgeable of US and international regulations, requirements and guidance associated with scientific publications or clinical regulatory document preparation and submissions. Knowledge and experience with Common Technical Document content templates. Working knowledge of current electronic document management systems and information technology.
  • Excellent written and oral communication skills. Superior attention to detail. Ability to find and correct errors in spelling, punctuation, grammar, consistency, clarity and accuracy. Experience in working with collaborative, cross-functional teams, including project management experience.
  • Experienced in word processing, flow diagrams, and spreadsheets. Excellent working knowledge of software programs in Windows environment.AbbVie is an equal opportunity employer including disability/vets. It is AbbVie's policy to employ qualified persons of the greatest ability without discrimination against any employee or applicant for employment because of race, color, religion, national origin, age, sex (including pregnancy), physical or mental disability, medical condition, genetic information, gender identity or expression, sexual orientation, marital status, status as a disabled veteran, recently separated veteran, Armed Forces service medal veteran or active duty wartime or campaign badge veteran or a person's relationship or association with a protected veteran, including spouses and other family members, or any other protected group status. We will take affirmative action to employ and advance in employment qualified minorities, women, individuals with a disability, disabled veterans, recently separated veterans, Armed Forces service medal veterans or active-duty wartime or campaign badge veterans. The Affirmative Action Plan is available for viewing in the Human Resources office during regular business hours.

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