Title: Clinical Research Scientist

Duration: 12 months
Work Location: Madison, NJ
Job Description:
Serve as clinical expert for assigned clinical trials within the product team and is expected to
provide input to decisions that may have clinical implications relative to his/her expertise.
Provide guidance to Project Team on realistic clinical timelines and budgets.
Responsible for clinical trial design across all Phases of clinical research for one or more
projects across multiple therapeutic areas
Coordinate and drive assigned clinical research studies with appropriate global and regional
functions.
Assist in protocol-related training of clinical investigators
Oversee study conduct in collaboration with Clinical Operations and Biometrics
Work with Clinical Operations, CROs and trial sites to ensure expedient patient recruitment.
Accurately interpret clinical study results and generate clinical study reports in collaboration
with Biometrics
Effectively collaborate with Global Franchise teams members and within the Clinical
Development organizations to ensure study design and results are accurately communicated
Write/review clinical efficacy and safety sections of regulatory dossiers.
Ensure submission documents are accurate and of high quality.
Support Standard Operating Procedures (SOPs), Good Clinical Practices, and all work processes
to ensure the efficient & compliant clinical operation of studies conducted within PCH. See
Agency Supplied material for Qualifications and Job summary No Overtime/ some travel
Educational Qualifications:
Advanced degree required (MD, PhD, or PharmD)
Minimum of 3-5 years of clinical research experience in the pharmaceutical industry
Experience in Rx-to-OTC Switch or analgesic clinical drug development strongly preferred
TECHNICAL SKILL REQUIREMENTS
Knowledge of drug development (all phases of the clinical research process including protocol
and case report form design, etc)
Knowledge of GCP/ICH guidelines and FDA regulations
Capable of designing innovative clinical programs/clinical studies
Ability to interpret clinical study results across multiple therapeutic areas
Excellent verbal and written communication skills
Superior decision making and problem solving
Well-developed writing and editing skills that can be applied to a wide range of scientific
documents
Experience in writing clinical portions of regulatory dossiers highly preferred
Excellent interpersonal skills; detail oriented, with ability to work in a fast-paced environment
Ability to effectively work in a cross-function matrix environment
Proficient experience in MS Word, Excel, PowerPoint, and Outlook
Skills:
-

Candidates must be located in Madison, NJ, possible work from home 1-2 days per week,
down the road depending on worker's performance.
Must have heavy experience in clinical development, protocol writing and study
reports, study design and planning.
Must have an advanced degree must be a doctoral level candidate, will take an MD that is not
US trained. Work independently.
Need to be strong on the scientific side less on the operations side.
Broad therapeutic experience is ok.
OTC experience is a plus
Clinical studies phase experience 1-4, any phase ok.

Associate director or junior to that would be appropriate. Needs to be hands-on.

Phone interview and then in-person. May consider a skype interview. Would consider someone
who will relocate. MUST be on-site in Madison. Need to fill this role asap.
(Scientific OR medical) AND (clinical trial design OR clinical research OR clinical
operations OR analgesic OR Rx to OTC OR Rx-to-OTC OR clinical development
OR protocol writing OR drug development OR study design OR planning) AND
(GCP OR ICH OR FDA)
clinical trial design
Rx-to-OTC Switch or analgesic clinical drug development
clinical research studies
(clinical trial design OR clinical research OR clinical operations OR analgesic OR
Rx to OTC OR Rx-to-OTC OR clinical development OR protocol writing OR
drug development OR study design)