PRINCIPAL INVESTIGATOR - ASSOCIATE MEDICAL DIRECTOR
Company: Pharmaceutical Product Development, LLC
Location: Austin
Posted on: February 21, 2021
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Job Description:
Principal Investigator - Associate Medical Director Job
Description We are vital links between an idea for a new medicine
and the people who need it. We are the people of PPD - thousands of
employees in locations worldwide connected by tenacity and passion
for our purpose: to improve health.---You will be joining a
truly---collaborative and winning culture as we strive to bend the
time and cost curve of delivering---life-saving therapies to
patients.
Our detailed, goal-oriented team members manage the safety profile
of new drugs in clinical trials, oversee case-processing activities
through all phases of development and perform regulatory reporting
and medical monitoring tasks.
As an Associate Medical Director you will provide medical oversight
of clinical trials to ensure company SOPs, client directives, good
clinical practice, and regulatory requirements are followed.
At PPD we hire the best, develop ourselves and each other, and
recognize the power of being one team. We offer continued career
advancement opportunities, award winning training and benefits
focused on the health and wellbeing of our employees.
Summarized Purpose:
Provides medical oversight of clinical trials to ensure company
SOPs, client directives, good clinical practice, and regulatory
requirements are followed. Attends and presents at investigator and
sponsor meetings, provides medical consultation to clients,
investigators and project team members and supports business
development activities.
Provides medical review and analysis for clinical trial serious
adverse events, marketed products ICSR and periodic safety reports
( e.g. PBRER, PSUR, DSUR) as well as other client deliverables
(e.g. labeling reconciliation documents, CTD modules, REMS, RMP and
CSR).
Essential Functions:
Manages all medical aspects of contracted tasks across the
pharmaceutical product life-cycle.
General Support:
MD or equivalent required. Active medical licensure preferred.
Candidates should have at least one of the following:
Clinical experience in treating patients in the specialty or
sub-specialty associated with the applicants training (comparable
to 2 years); Or
Suitable clinical trial experience in a Contract Research
Organization, pharmaceutical company or as a principal investigator
(comparable to 1-2 years) in the industry; Or
Direct experience in safety/Pharmacovigilance (comparable to 2
years).
In some---cases---an equivalency, consisting of a combination of
appropriate education, training and/or directly related experience,
will be considered sufficient for an individual to meet the
requirements of the role.
Knowledge, Skills and Abilities:
PPD values the health and wellbeing of our employees. We support
and encourage individuals to create a healthy and balanced
environment where they can thrive. Below is listed the working
environment/requirements for this role:
Able to communicate, receive, and understand information and ideas
with diverse groups of people in a comprehensible and reasonable
manner.
Able to work upright and stationary for typical working hours.
Ability to use and learn standard office equipment and technology
with proficiency.
Able to perform successfully under pressure while prioritizing and
handling multiple projects or activities.
May require travel. (Recruiter will provide more details.)
PPD Defining Principles:
- We have a strong will to win - We earn our customer's trust - We
are gamechangers - We do the right thing - We are one PPD -
If you resonate with our five principles above, and ultimately wish
to accelerate the delivery of safe and effective therapeutics for
some of the world's most urgent health needs, then please submit
your application - we'd love to hear from you
Diversity Statement PPD is proud to be an affirmative action
employer that values diversity as a strength and fosters an
environment of mutual respect. PPD is committed to providing equal
employment opportunities without regard to age, race, color,
pregnancy, national origin, religion, sex, gender identity, sexual
orientation, disability, veteran status or status within any other
protected group.
Keywords: Pharmaceutical Product Development, LLC, Austin , PRINCIPAL INVESTIGATOR - ASSOCIATE MEDICAL DIRECTOR, Executive , Austin, Texas
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