05 ago
|
TFS HealthScience
|
Cataluña
05 ago
TFS HealthScience
Cataluña
About this role TFS HealthScience is a leading general
mid-size Contract Research Organization (CRO) that partners with
biotechnology and pharmaceutical companies throughout their entire
clinical development journey. Our expertise includes full-service
capabilities, resourcing, and Functional Service (FSP) solutions.
The Senior Medical Writer will be responsible for the scientific
accuracy, data and referencing quality, appropriate style, and
correct branding of scientific/medical assets for the client
globally. The Senior Medical Writer will work in an international
and cross-functional environment, following global and local
guidelines and working closely with internal and external
stakeholders to ensure the highest quality for company assets and
gathering data on asset quality and agency performance. As part of
our SRS/FSP team, you will be dedicated to one sponsor, a global
pharmaceutical or biotechnology company that is an industry leader
within its therapeutic area. Key responsibilities - Perform
data/referencing quality check of scientific/medical assets;
ensuring all content is scientifically accurate and appropriately
supported by the Reference Documents. - Review content and identify
any non-compliances with the local regulatory guides. - Perform
some actions in the Review and Approval platform (Veeva Vault) such
as reference tagging or claims object creation. - Check
anchors/links to references required to support the
scientific/medical assets. - Identify assets that may require
pre-alignment with internal stakeholders. - Flag claims that may be
difficult to substantiate or do not follow regulatory/internal
guidelines. - Track asset quality data for internal and external
reporting. Qualifications - Experienced Medical Writer or Medical
Content Reviewer (3-5 years), with a scientific background and
degree (PharmD, MD, PhD or Masters),
at least 3 years producing or
reviewing content for the Pharma/Biotech industry. - Excellent
medical writing skills. - Strong attention to detail and accuracy,
ability to manage and prioritize multiple, detailed activities,
results-orientated with fast and focused execution. - Good
communication, coordination and time management skills. - Fluent in
oral and written English AND Portuguese. - Ability to work within a
team or across multiple teams (including remotely) as well as
independently. - Values teamwork and collaboration, diversity and
inclusion, and innovation. - Prior experience working in content
creation for Biotech/Pharma, would be advantageous. - Prior
experience working in any of the therapeutic areas: Metabolism,
Cardiovascular Diseases, Chronic Kidney Disease, Respiratory,
Inflammation; would be advantageous - Prior experience with the
Pharmaceutical Content Review process and/or Veeva Vault would be
advantageous What We Offer We provide opportunities for personal
and professional growth in a rewarding environment. You will join a
team that values collaboration, quality, and making a difference in
the lives of patients. Our core values of Trust, Quality, Passion,
Flexibility, and Sustainability guide our decisions and shape our
culture. By aligning on these values, we foster collaboration,
innovation, and a shared commitment to excellence. Together, we
make a difference. A Bit More About Us Our journey began over 30
years ago in Sweden, in the city of Lund. As a full-service global
CRO, we build solution-driven teams working toward a healthier
future. Bringing together over 600 professionals, TFS delivers
tailored clinical research services in more than 50 countries,
offering flexible clinical development and strategic resourcing
solutions across key therapeutic areas including Dermatology,
Neuroscience, Oncology, and Ophthalmology.
📌 Senior Medical Writer (Portuguese speaker) (Cataluña)
🏢 TFS HealthScience
📍 Cataluña