Match score not available

Client Site TMF Specialist

unlimited holidays - extra holidays - extra parental leave - long remote period allowed

Remote:

Full Remote

Experience:

Mid-level (2-5 years)

Work from:

United States

Offer summary

Qualifications:

3+ years regulatory document experience in pharma, biotech, CRO., Proficiency in Microsoft Office and TMF Reference Model..

Key responsabilities:

Review essential regulatory documents for conduct of clinical studies.
Collaborate in a fast-paced team environment.

TransPerfect XLarge https://www.transperfect.com/

5001 - 10000 Employees

See more TransPerfect offers

Job description

TransPerfect Is More Than Just a Job…
Our greatest asset is our people, and nothing is more important to us than ensuring that everyone knows that. Each of our 90+ offices has its own individual identity, and each also has its own unique rewards.

Locations:

US-NJ (Remote)

TransPerfect is recruiting a Trial Master File Specialist II to work on a Contract Document Review Project. Details and requirements are below:

Start date: ASAP

Duration: 8 months

Location: South Plainfield, New Jersey. You will be on client site.

Hourly Rate: $50 per hour

Hours: 40 hours per week

Experience: 3 years working with regulatory documents in a pharma, biotech, CRO or related environment, including:

Thorough knowledge of essential regulatory documents required for the conduct of clinical studies, as described in the ICH E6 Guidelines and in relevant regulations (e.g., Food and Drug Administration (FDA) 21 CFR).
Knowledge and working experience with TMF Reference Model.
Proficiency with Microsoft Office.
Excellent verbal and written communication and skills.
Ability to work independently and collaboratively, as required, in a fast-paced, matrixed, team environment consisting of internal and external team members.
Analytical thinker with excellent problem-solving skills and the ability to adapt to changing priorities and deadlines.
Excellent planning, organization and time management skills including the ability to support and prioritize multiple projects.

Preferred qualifications include:

Associate’s and/or Bachelor’s degree.
Experience using eDMS software.
Demonstrated experience identifying, developing, and implementing improvements to departmental processes that increase efficiency and that maintain or improve quality (e.g., increasing the numbers of documents processed).

TransPerfect provides equal employment opportunity to all individuals regardless of their race, color, creed, religion, gender, age, sexual orientation, national origin, disability, veteran status, or any other characteristic protected by state, federal, or local law.