Principal Medical Writer
Posted on: June 14, 2022
Principal Medical WriterCandidates, please include a cover
letter.Remote OpportunityJob OverviewThe Principal Medical Writer
will act as Lead Medical Writer on any type of writing project,
including projects with multiple deliverables or components; Will
prepare assigned documents in accordance with IQVIA Standard
Operating Procedures (SOPs) and customer requirements to the agreed
timelines; Will perform senior review of all types of medical
writing deliverables; Will provide feedback and guidance to more
junior staff; Will negotiate timelines and discuss and resolve
customer comments; Will keep abreast of current medical writing and
regulatory knowledge, including Good Clinical Practice (GCP), along
with developments and advances in drug development and medical
- Take a leading role in preparing assigned documents, including,
but not limited to, confirming the scope of the task, confirming
templates and specifications, negotiating and adhering to
timelines, organizing document reviews, communicating directly with
- Plan and organize workload for assigned projects and tasks:
identify project needs, track timelines and implement customer
- Use experience and initiative to tackle new or unusual document
types and customer requirements.
- Chair meetings. Able to act as point of contact for escalations
and resolve conflict.
- Participate in bid defense meetings and discussions.
- May design training materials and input into generic training
plans for staff. Proposes topics for and prepares and delivers
knowledge-sharing sessions for the global team. May propose, plan
and deliver general training on Medical Writing to other IQVIA
groups and externally, as appropriate.
- May act as Project Manager for a small series of Medical
Writing projects, that may involve elements of other
- Complete project finance activities, including monitoring and
forecasting budgeted hours.
- Independently propose, review and approve budgets and
assumptions for a range of project types within remit.
- May take on a partnership lead role.
- Likely to represent region or site on a Medical Writing
initiative or cross-functional initiative.
- May draft new Medical Writing Standard Operating Procedures
(SOPs) for review and act as reviewer for Medical Writing SOPs, as
assigned and appropriate.Qualifications
- Bachelor's Degree in life sciences related discipline or
related field is Required; Master's Degree and/or Ph.D. in life
sciences related discipline or related field is Preferred.
- Typically requires at least 7 years of highly relevant
experience and related competency levels, including extensive
experience in preparing CSRs and protocols independently to a
consistently high standard.
- In-depth knowledge of the structural and content requirements
of clinical study reports, protocols, and similar documents and
ability to identify deficiencies, errors, and inconsistencies in
- Good understanding of common statistical methods used in
clinical trials and interpretation of their results.
- Ability to effectively review a statistical analysis plan and
to identify deficiencies, errors, and inconsistencies in
- Ability to integrate, interpret, and summarize data from a
variety of sources in a clear and concise manner.
- Extensive experience in preparing CSRs and protocols
independently to a consistently high standard, regardless of
complexity or challenges.
- Experienced in preparing CTDs and tackling new or unusual
document types and customer requirements.
- In depth knowledge of drug development, medical writing, and
associated regulations. Good understanding of statistical
principles and of medical terminology across a range of therapeutic
- Excellent written and oral communication skills including
grammatical/technical writing skills.
- Excellent attention to detail and accuracy.
- Confident and effective communication and negotiation skills
with customers and project managers.
- Demonstrated ability to remain calm and assertive yet
diplomatic in more challenging interactions with customers and
- Demonstrates initiative and sound judgement when faced with
less familiar project/document situations or challenges.
- Demonstrated abilities in collaboration with others and
- Demonstrated ability to influence others without having
- Demonstrates good judgement in requesting input from senior
- Ability to establish and maintain effective working
relationships with coworkers, managers and customers at a senior
- Experienced and effective in providing feedback and guidance to
more junior staff.
- Ability to effectively manage multiple tasks and projects.
Decisive amongst competing priorities.
- Confident in raising and discussing sensitive topics without
- Ability to proactively evaluate risks and potential issues and
seek solutions and discuss appropriately with colleagues and
customers. Confidence in appropriately challenging the customer
when document quality or timelines are at risk.
- Must be computer literate.#LI-remoteIQVIA is a leading global
provider of advanced analytics, technology solutions and clinical
research services to the life sciences industry. We believe in
pushing the boundaries of human science and data science to make
the biggest impact possible to help our customers create a
healthier world. Learn more at https://jobs.iqvia.comWe are
committed to providing equal employment opportunities for all,
including veterans and candidates with disabilities.
https://jobs.iqvia.com/eoeAs the COVID-19 virus continues to
evolve, IQVIAs ability to operate and provide certain services to
customers and partners necessitates IQVIA and its employees meet
specific requirements regarding vaccination status.
Keywords: IQVIA, Lynn , Principal Medical Writer, Healthcare , Lynn, Massachusetts
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