Senior Medical Writer, Late Phase - Remote
Company: Laboratory Corporation
Location: Honolulu
Posted on: January 16, 2022
Job Description:
Job Overview:Senior Medical Writer, Late Phase Remote: US or
Canada - -Medical Writers in the Late Phase group is responsible
for preparation and coordination of clinical study protocols and
clinical study reports (CSRs), and other documents as needed.
Provide support for and participate in development of submission
level documents under guidance of senior staff. Production of
scientific publications and other documents (e.g., abstracts,
posters, manuscripts, etc.). Interpretation of clinical,
pharmacokinetic, pharmacodynamic and statistical results as
appropriate. Oversees and coordinates activities of other writers
on higher complexity narrative projects. Ensure timely delivery of
high quality documents to internal customers and Sponsors.
Provision and development of intra- and inter-departmental
training. Works with the management team to provide guidance and
mentoring to Medical Writers to ensure best working practices are
maintained. Scientific presentations both internally within Labcorp
Drug Development and externally (e.g., conferences). Represents the
company at scientific meetings and meetings with clients. Foster
excellent working relationships with all clients, both internal and
external, with the highest quality of service in a cost-effective
manner on time, every time.
Write and coordinate the development
of protocols, CSRs or other clinical documents including those of a
more complex nature Provide support in development of submission
level documents under guidance of senior staff Oversees management
and coordination of complex narrative projects Produces scientific
papers, abstracts and/or posters, and presentations. Responsible
for all medical writing aspects of project development and
coordination, adherence to timelines and budget To prioritize and
plan workload to a high standard. Effectively manage multiple
assignments in parallel Prepare documents in accordance with
Labcorp Drug Development/Client Standard Operating Procedures and
specifications as applicable, and relevant ICH and
regulatory/industry guidelines Review of Statistical Analysis Plan
(SAP) and Tables, Figures and Listings (TFLs) to ensure appropriate
data presentation for CSR purposes. Provide feedback on SAP and
TFLs to project team as needed. Act as medical writing contact for
major clients and partners Keep up to date with developments in
Medical Writing In consultation with more experienced staff, show
initiative and ability to deal with complex project situations
Inform management of medical writing problems promptly and propose
solutions Provide advice on Medical Writing issues to project team
members (internal and external) and help to resolve problems
Contribute to Medical Writing initiatives to develop and improve
processes Mentor and provide guidance and training to other medical
writing staff Provide peer review and input on deliverables
prepared by colleagues Provides scientific leadership and support
to colleagues in the data management and reporting team Provide
support for Business Development opportunities such as time and
cost estimates, attendance at client bid defense meetings, industry
conferences Review Labcorp Drug Development SOPs and associated
documents Represent department in audits and inter-department
working groups Comply with Labcorp Drug Development internal
processes and procedures Performs other duties as assigned by
Management Education/Qualifications:Minimum of first degree in life
sciences (or equivalent); advanced degree (e.g., PhD or Masters)
preferred. Experience:
Typically minimum 4 years medical
writing experience including 2 years as medical writing project
lead Excellent command of written and spoken English Excellent
written and verbal communication skills In-depth knowledge of MS
Word Excellent organizational and time management ability Detailed
knowledge of ICH guidelines applicable to medical writing Good
understanding of medical/scientific terminology and experience in
data analysis and interpretation
Keywords: Laboratory Corporation, Honolulu , Senior Medical Writer, Late Phase - Remote, Advertising , Honolulu, Hawaii
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