Principal Medical Writer, Medical Affairs (Clinical)
Company: ProPharma Group
Location: Clifton Park
Posted on: May 16, 2022
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Job Description:
Company DescriptionProPharma Group is an industry leading,
single source provider for regulatory compliance,
pharmacovigilance, and medical information services across the full
development lifecycle for pharmaceutical, biotechnology, and
medical device companies. Operating around the world with offices
in Australia, Canada, Germany, Japan, the Netherlands, Sweden,
United Kingdom, and the United States, ProPharma Group's fully
integrated service offerings will provide clients with a
comprehensive suite of global support services that are required to
be competitive in today's dynamic markets. We build successful
long-term relationships with clients by providing leading industry
knowledge, experience, and proven processes.Job DescriptionThe
Principal Medical Writer, Medical Affairs is responsible for
researching, writing, and editing medical affairs documents by
applying functional expertise and medical affairs knowledge. The
position is expected to exhibit excellent written and oral
communication and presentation skills, and to demonstrate expert
level technical expertise and background in the use of medical
writing templates and software. Additionally, they will also be
responsible for ensuring compliance to company regulations,
internal procedures, applicable industry standards (e.G., GPP3,
ICMJE, CONSORT, STROBE) and policies in cooperation with colleagues
and clients.Essential Functions IncludeThe Principal Medical Writer
independently leads all aspects of the medical writing process
including organization, content, timelines, and resource
requirements.Experience and ability to lead publication planning
according to industry standards and in accordance with client's
product development goals.Demonstrates technical expertise and
background in the use of medical writing templates and software and
ability to create relevant document templates as
needed.Independently leads the document preparation process,
including but not limited to: literature search/selection, content
development, receive and review primary outputs, draft and
distribute documents for review, and incorporate/resolve comments
with all contributors and/or reviewers.Leads the activities of the
project team, including contract employees or vendors (on-site or
external), and provides review and substantive editing of
contributions, ensuring resolution of issues.Serves as an expert in
advances and technological changes in medical affairs services
within the pharmaceutical / device / biotech industries and
promotes those that will increase the company's effectiveness and
profits.Serves as a led on medical affairs on cross-functional
teams and task forces relative to projects, process, and
standards.Leads collaboration with colleagues for the purpose of
attaining bid opportunities.Develops and delivers in-house staff
and external training.Applies effective risk assessment and
management principles to identify and address project risks and
resolves problems.Promotes the firm's reputation through high
quality project outputs and good client relations.Work related
travel as required.Other duties as assigned.Qualified Candidates
Must HaveQualificationsM.S./M.A. in a relevant clinical and/or
scientific discipline as a minimum, doctorate level preferred.
Bachelors degree will be considered with appropriate level of
experience.Minimum 7 years' experience in a relevant medical
writing role in the pharmaceutical/CRO industry/biotechnology
industry.Expert level, working knowledge of current requirements
and guidelines applicable to medical affairs/medical communications
documents e.G., GPP3, ICJME.Strong verbal and written communication
skills.Strong computer knowledge including Microsoft Office
products.CMPP certification, or ability to obtain this
certification, required.Ability to independently develop and manage
schedules and budgets.Strong knowledge of applicable GPP3, ICJME
and other applicable industry standards and guidance
documents.Ability to independently manage multiple projects
simultaneously and mentor others in the same, according to sound
project management principles.Ability to understand, interpret, and
synthesize clinical and scientific data at an expert level and
train others to perform this function effectively.Effective written
and oral communication skills; ability to write, type,express or
exchange ideas; ability to convey information/instructions
accurately.Ability to interact in a professional and positive
manner with clients and co-workers.Expert level of understanding of
the criteria for medical affairs services in the pharmaceutical,
medical device and biotech industries.Strong understanding of the
bidding/proposal process in these industries.Proven record with
problem solving, project tracking, budgeting, and facilitation of
efficient communication between the client and the team.Quality
orientation and high attention to detail.Flexibility to work
occasional weekends and evenings.Additional InformationAll
candidates must be legally eligible to work in the United States.We
are an equal opportunity employer. M/F/D/V***ProPharma Group does
not accept unsolicited resumes from recruiters/third parties.
Please, no phone calls or emails to anyone regarding this
posting.***
Keywords: ProPharma Group, Albany , Principal Medical Writer, Medical Affairs (Clinical), Advertising , Clifton Park, New York
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