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Senior Transparency Specialist (CRO or Pharma) - Remote

Remote:

Full Remote

Contract:

Full time

Experience:

Senior (5-10 years)

Work from:

United States

Offer summary

Qualifications:

Bachelor’s Degree in a scientific, medical, or clinical discipline preferred, At least 3 years of previous transparency experience, Hands-on experience with clinical trials and pharmaceutical development, Experience in pharmaceutical or CRO industry preferred, Strong attention to detail.

Key responsabilities:

Provide high-quality transparency deliverables efficiently
Facilitate the progression and completion of information exchange
Perform quality control reviews of document redaction
Maintain understanding of regulations and ensure compliance
Lead projects independently and prioritize multiple deliverables

MMS SME https://www.mmsholdings.com

501 - 1000 Employees

See more MMS offers

Job description

Are you looking to join a company where your contributions truly matter, and where you'll be part of a supportive, innovative team? MMS is a award-winning, data-focused clinical research organization (CRO). We pride ourselves on being a Great Place to Work certified organization, recognized for our exceptional culture and industry best employee retention rate. We support the pharmaceutical, biotech, and medical device industries with our proven, scientific approach to complex trial data and regulatory submission challenges. With a global footprint across four continents, MMS not only maintains an industry-leading customer satisfaction rating but also fosters a collaborative and inclusive work environment where employees can thrive. Join us at MMS and be part of a team that is shaping the future of clinical research.

Discover more about our exciting opportunities and why MMS is a great place to advance your career. Visit www.mmsholdings.com or follow MMS on LinkedIn.

The Senior Transparency Specialist will provide operational support of:

Clinical Trial Transparency
Clinical Trial Data Sharing
Redaction and anonymization of clinical trial documents in accordance with evolving global regulations

Responsibilities:

Responsible for providing high-quality transparency deliverables in an efficient manner.
Technical expertise on regulatory requirements (EMA Policy 0070, HC PRCI, EU-CTIS etc.).
Facilitates the initiation, progression and completion of the exchange of information for all Transparency workflow steps, with skill and proficiency.
Performs quality control reviews of document redaction or anonymization to ensure consistency and accuracy.
Maintain a strong understanding of regulations and guidance’s as they pertain to transparency; ensure deliverable timelines are compliant with regulatory timelines.
Lead projects with minimal management oversight, including complex projects with multiple team members; coordination independently with the client.
Tailors communication to diverse audience considering experience, background, and expectations.
Anticipate and understand customer’s needs and preferences and can provide solutions to customer’s needs; Develops deliverables according to customer specifications.
Effectively manage/ prioritize multiple deliverables and delegate as needed or implement workable solutions to complete deliverables on time.
Capable of leading Transparency process/tools improvements initiatives and may participate in complex companywide process improvement initiatives.
Facilitates and fosters positive team environment while supporting independent action to achieve team goals.
Experience with identifying CCI a plus.

Requirements:

Bachelor’s Degree in a scientific, medical, or clinical discipline or related field is preferred; or 5 years of experience if less than a Bachelor’s.
At least 3 years of previous transparency experience.
Hands-on experience with clinical trials and pharmaceutical development preferred.
Effective problem-solving and data analysis skills.
Experience in the pharmaceutical or CRO industry highly preferred.
Has a strong attention to detail.