Senior Medical Writer (Remote)
Posted on: March 19, 2023
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
- 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
- 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
- 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
- Bachelor's degree in English or Communications with relevant
science expertise or Bachelor'sdegree in Life Science with relevant
- 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
- American Medical Writing Association (AMWA) certification or
other is preferred, with a specialty in Editing/Writing or
- 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
- 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.
Keywords: AbbVie, Raleigh , Senior Medical Writer (Remote), Advertising , Raleigh, North Carolina
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