Seeking individual with experience in regulatory submission writing for closed and closing Phase I and II clinical trials; experience with clinical trials for therapeutic drugs, vaccines, medical devices considered.

Requires knowledge of, and direct experience with:

*** Regulations governing clinical trial documentation.

*** CFR 21 parts 11, 50, 56, 58, 312, and 314.

*** Electronic Common Technical Document (eCTD) formatting, publishing, and submission requirements.

*** Developing, writing, editing, and updating Investigator's Brochures (IBs), Periodic Safety Update Reports (PSURs), Clinical Study protocols and reports, Case Report forms, etc.

*** AMA (American Medical Association) style guide.

Total compensation package includes competitive salary and bonus potential to $100,000. Company covered medical, dental, and vision expenses; matched 401(k) contribution, annual reviews and potential raises, and long term growth potential. Paid time off for vacations, personal days, sick days, and holidays.

The compensation is attractive of course, and the long-term benefits are exceptional too! Join a company where you can take advantage of company sponsored training programs, tuition reimbursement, and company paid membership fees and certification renewal fees. Plenty of upwards internal growth potential within a company that grooms top performers for management roles and promotes from within.

For details contact Branden F. Lynch at:
(609) 584-9000 ext 241

Or submit resume online at:
http://dmc9.com/bfl/app.asp

Or email to:
1000025879_10007337@jobbank302.com

Please reference #37133145 when responding.

5+ years

Maryland

$70,000.00

$100,000.00

Branden F. Lynch

(609) 584-9000 ext 241

1000025879_10007337@jobbank302.com

http://dmc9.com/bfl/app.asp

WE ARE AN EQUAL OPPORTUNITY EMPLOYER and our employment decisions are made without regard to race, color, religion, age, sex, national origin, handicap, disability or marital status. We reasonably accommodate individuals with handicaps, disabilities and bona fide religious beliefs. Jobs Career Position Hiring. CONSIDERED EXPERIENCE INCLUDES: http://najobbank.com www.najobbank.com Top 10 Job Site Top 10 Careers Site Regulatory Medical Writer Clinical Trials Regulatory Affairs Regulatory Operations Phase I Phase II Clinical Studies Clinical Study IND Investigational New Drug Application IRB Institutional Review Board Vaccine Small Molecule Biologic Medical Device Med Device Safety Reports Study Protocols GCP Good Clinical Practice Pharmaceutical CRO Contract Research Organization CSR Clinical Study Report Biotech AMA American Medical Association

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