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Medical Director

Posted on Jun 4, 2020 by Sterling Hoffman Life Sciences

Springfield, MA
Health Care
Immediate Start
Annual Salary
Full-Time


partial list of responsibilities. If you wish to apply, simply click the
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Job_Description

==============================================

Responsibilities_Include

Our client, a leading biopharmaceutical company, is currently recruiting a
Medical Director who will infuse the Medical Team with their talent, energy and
leadership skills. This is an exceptional opportunity to join a corporate
culture that is known for its innovative and growth-oriented vision.
* Act as a global medical and safety monitor for assigned clinical trials
* Oversee all medical, scientific and safety aspects of assigned clinical
trials
* Direct protocol implementation, including site identification and
communication and attend investigators meetings
* Collaborate with global team members on trial execution
* Provide medical expertise in the development, review and approval of CRF
and ICF design and site source documents
* Lead the review, analysis and interpretation of study data
* Support data analysis and assemblies
* Manage medical assessment and review, signal detection and health hazard
evaluation activities
* Review the listing and narrative summaries for regulatory submissions
* Prepare and review advertisement hoc documents required in response to
requests from the FDA and other regulatory agencies
* Work with internal resources and outsource partners to oversee and manage
all drug safety and surveillance activities for clinical trial phases
* Utilize epidemiology tools and medical judgment to conduct ongoing
evaluation of potential safety signals
* Provide medical input to the assessment of emerging safety information
from clinical trials
* Contribute to safety sections of product labeling reviews
* Supervise the performance of Safety contractors
* Interact closely with the Regulatory Department and agencies
* Prepare, review and approve the clinical study- and safety-related
portion for INDs, NDAs and ANDAs and their amendments and supplements
* Prepare, review and approve product labels and packaging inserts for NDA
submissions
* Provide medical expertise in the review of adverse events and manage
pharmacovigilance activities
* Make final determination as to whether an adverse drug event is serious,
unexpected and periodic
* Respond to FDA's possible questions regarding medical and safety matters
during FDA interactions
* Attend in-person meetings and teleconferences with the FDA and other
regulatory and business entities
* Evaluate safety data and develop R&D risk management initiatives
* Serve as a content owner for assigned clinical trial and other documents
* Conduct protocol development to include working closely with medical
writing and project teams
* Write the clinical sections and review all clinical documents related to
the assigned clinical studies
* Provide medical and scientific input and drive contributing to the
creation of these documents
* Collaborate with other contributors to these documents to ensure overall
consistency and quality
* Participate in program development, including working cross-functionally
with all of the disciplines necessary for successful drug development
* Interact closely with the Pre-Clinical Team to understand the scientific
basis of targeted therapies
Qualifications_And_Desired_Skills
* A university degree is required. Although all candidates are welcome and
encouraged to apply, preference will be given to those with degrees in a
relevant field
* Appropriate full-time work experience is mandatory (no students or fresh
graduates please)
* Recent experience in the biopharmaceutical industry is strongly preferred
* Preference will be given to candidates with recent experience in medical
management
For the right leader, this is a wonderfully rewarding role with tremendous
growth prospects. If you are qualified and think you're a strong fit for this
role, please apply ASAP. We thank all applicants, but only candidates who meet
our client's criteria will be contacted.

More questions? Want to know the Salary range? Keep reading.

Tips_And_Suggestions
* To view other jobs of interest, go to: https://

* If you have questions about this position, the best way to get answers is
to first APPLY to the position via LinkedIn. That way, we know you are
genuinely interested. After you apply, a Recruiter will call you within 7
days (as long as we believe the position is a good fit for your
background, of course).
* If you think you are interested, apply NOW - not later. The sooner you
apply, the higher your chances of being considered for the role. Why?
Because sometimes job postings will close if we receive too many
applications.
* To get a status update on your application, send us a private message on
TWITTER: @SterlingHoffman
Here_Is_The_Link_To_The_Job_Description_Again



Reference: 26449008

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