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Lead Medical Writer - PSS

Employer
Labcorp
Location
EUROPE
Salary
Competitive
Start date
1 Dec 2021
Closing date
2 Dec 2021

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Discipline
Clinical Research, Drug Safety, Pharmacovigilance
Hours
Full Time
Contract Type
Permanent
Experience Level
Experienced (non-manager)
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Job Details


Labcorp are recruiting a Lead Medical Writer to work outsourced to one of our clients. Candidates can work home based anywhere within Eastern Europe. It's key for candidates to have experience of signal detection/aggregrate reporting for more than 5 years.

Role responsibilities will include but not limited to:
  • Conducting literature searches for authoring various types of reports.
  • Write and review various safety reports (or part of such reports) for global regulatory submissions, including Annual Reports (IND and other), Periodic Safety Update Reports/ Periodic Benefit Risk Evaluation Reports, Periodic Adverse Drug Experience Reports, Bridging reports and other clinical documents as assigned.
  • Write Common Technical Document Summaries including Non Clinical and Clinical Overviews, Clinical Summaries and other regulatory documents as assigned.
  • Write Investigator Brochures and sections of/entire protocols
  • Write Clinical Study Reports (in whole or in part) for Phases 1-4 trials, including full study reports, abbreviated reports, web synopses, subject narratives.
  • Author Informed Consent Forms (ICFs), manuscripts, abstracts, posters for conferences.
  • Resolve and/or escalate issues in a timely manner.
  • Timely escalation of unresolved issues to internal and external (client) point of contact.
  • Support and contribute to onboarding, training, mentoring, and coaching of new associates.
  • Prepare medical information responses for HCPs.
  • Act as a writing coach.
  • Coordinate activities related to various types of report writing across a team of writers if applicable.
  • Liaise with client and act as a primary point of contact for all report writing activities.
  • Perform various support activities such as tracking, maintenance of metrics, performing and documenting quality checks and training.
  • Assist in estimation of resource requirement and responding to RFPs as needed.
  • Internal and external (client) communication & co-ordination to get the required inputs.
  • Get resolution on issues affecting project deliverables.
  • Creating and updating labels, , e.g. Core Data Sheets, USPI, centralized SPC's, Med Guides.
  • Search literature databases for relevant information, recommend label changes, author proposed label text and preparation of supporting/justification document.

#LI-NC1 EMEA
Education/Qualifications:
  • Master's degree in Pharmacy/related science area
  • Bachelor's degree in Medical Science
Experience:
  • At least 5-7 years' experience in the pharmaceutical industry, with at least 4 years of it in medical writing.
  • Experience in drug discovery and pharmacovigilance is desirable.
  • Candidates must be able to communicate effectively in the English language.

Company

At Labcorp, we believe in the power of science to change lives. We are a leading global life sciences company that delivers answers for crucial health questions —because we know that knowledge has the potential to make life better for all. Through our unparalleled diagnostics and drug development capabilities, we provide insights and accelerate innovations that not only empower patients and providers but help medical, biotech, and pharmaceutical companies transform ideas into innovations. Here, you can join our more than 70,000 employees, serving clients in more than 100 countries, as we work together to make a real impact on people’s lives. Join us in our pursuit of answers.

 

 

 

 

Company info
Website
Location
Maidenhead Office Park
Westacott Way
Littlewick Green
 Maidenhead
SL6 3QH
United Kingdom
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