Director Medical Writing
Location: San Diego
Posted on: October 12, 2021
in the US or EMEA
Director Medical Writing will ensure that the Medical Writing staff
is adequately trained and capable of delivering high quality
documents to internal and external clients. Develop a sense of
teamwork and common purpose among the staff, especially among the
writers, but extending to the entire Medical Writing group. Ensure
excellent communication and interaction within the Medical Writing
team and between Medical Writing and the wider teams within Labcorp
Drug Development. Support the Head of the group on short-term
and long-term strategies to improve efficiencies in the department.
Predict and plan resource requirements and staffing
awareness of new developments in Medical Writing and in the global
regulatory environment which may be applied to the management and
reporting of clinical trial data.
input into budgetary requirements, perform ongoing financial review
of projects, ensure that all issues are highlighted and resolved as
quickly as possible and that all non-contract tasks are identified,
tracked and included in change order forms.
input into salary reviews for direct reports and nominate for
promotion when ready.
all Medical Writing activities are carried out in accordance with
Labcorp Drug Development or project specific processes.
the quality work of the group and department through ongoing
quality management and review to ensure high quality deliverables
to clients and internal customers.
and maintain strategic client relationships and receive client
satisfaction surveys. Support corporate business development and
marketing activities at client presentations and professional
billability of Medical Writing staff.
that revenue and operating margin meet agreed targets.
that the staff are utilized as fully, but also as efficiently as
possible. Ensure that resource information is applied across
projects to increase utilization, improve efficiency or amend the
resource levels required on a project as necessary.
writing teams in the planning and execution of major regulatory
submissions (e.g., MAA, CTD).
deputize for the Head of the group
of first degree in life sciences (or equivalent); advanced degree
(e.g., PhD or Masters) preferred
minimum 10 years medical writing experience
people management skills and supervisory skills gained from a
minimum of 5 years line management experience.
of the relationship and regulatory obligation of the CRO industry
with pharmaceutical / biotechnological companies
understanding of clinical research, the drug development process,
and applicable regulatory guidelines
oral and written communication and presentation skills
to work consistently in a fast-paced, rapidly changing
thinking, attention to detail
Keywords: Labcorp, San Diego , Director Medical Writing, Other , San Diego, California
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