Job Details: Director, Disclosures & Transparency


JobsIreland
Jervis Street
Dublin 1
jobsireland.ie
Director, Disclosures & Transparency
My client, a world class Biopharmaceutical company now have a vacancy
for a Director, Disclosures & Transparency.

The Role:

The Disclosures & Transparency function resides organizationally
within Regulatory Documentation and Submissions (RDS) organization and
is responsible for Clinical Trial Disclosure and Data Transparency
activities. These activities include the registration of, and results
posting for sponsored clinical trials on appropriate Clinical Trial
Registries, the generation and facilitation of trial/clinical product
transparency activities and deliverables in accordance with relevant
laws, regulations, and policies. In addition, D&T is responsible for
managing the Individual Patient Data Sharing process with qualified
external requestors.

Essential Functions:

Partners with and leads interactions with International Regulatory
Affairs and demonstrates an ability to effectively collaborate
cross-functionally

Oversees compliance and maintain oversight over all Disclosure and
Transparency activities in Countries with mandatory D&T regulations
outside the US

Oversees registration of new protocols, maintenance of protocol
records, and results postings outside of the US

Oversees redaction of clinical trial documents for mandatory
regulations

Serves as a subject matter expert, primary point of contact outside
the US and corporate resource for the D&T group

Trains others on international regulatory and legal clinical trial
disclosure and transparency requirements

Support strategic Disclosures & Transparency initiatives within the
group and cross functionally

Support continuous improvement and ensures processes are efficient,
scalable, and effective

Participates in companywide process improvements and development of
initiatives

Acts as an advisor to various groups on appropriate strategies for
disclosures activities

Demonstrates exceptional operational and organizational skills to
ensure disclosures and transparency activities are performed on time
and with the highest of standards

Evaluates evolving regulations and public guidance on clinical trial
disclosure and data transparency to maintain Company compliance

Participates in group initiatives and authoring of training manuals,
checklist documents, business practices, or standard operating
procedures (SOPs)

Responsible for maintaining and oversight of routine metrics for
reporting to Head of D&T

Supports and Consults with internal core team and/or sub-teams on
strategic transparency initiatives.

Develops and maintains process and system to optimize efficiency,
maximize content reuse and ensure quality.

Knowledge, Experience & Skills:

A BS degree

Knowledge of Global Clinical Trial Transparency and Data Sharing
Requirement preferred.

A well-versed understanding of Regulatory requirements outside the US.

Typically, **Apply on the website**+ years of relevant clinical
development or regulatory affairs experience in the
pharmaceutical/biotechnology development environment (e.g. Sponsor or
Clinical Research Organization (CRO))

Preferably 5 or more years of direct experience in disclosures and/or
data transparency, clinical operations or medical writing/clinical
submissions.

Core understanding and familiarity with Clinical Development, Clinical
Trial conduct, and the Regulatory Submission process is preferred.

Essential:

Experience overseeing clinical trial disclosure activities and
partners with International Regulatory Affairs or Affiliates or local
CROs to ensure new protocol registrations/registration updates and
results postings are released on mandatory clinical trial registries
outside the US in a timely manner.

Has excellent verbal and written communication skills and
interpersonal skills. Can effectively communicate with a variety of
teams and individuals, including team leadership and members of senior
management staff.

For full details and confidential discussion contact Tina at 1 or
email My client, a world class Biopharmaceutical company now have a vacancy
for a Director, Disclosures & Transparency.

The Role:

The Disclosures & Transparency function resides organizationally
within Regulatory Documentation and Submissions (RDS) organization and
is responsible for Clinical Trial Disclosure and Data Transparency
activities. These activities include the registration of, and results
posting for sponsored clinical trials on appropriate Clinical Trial
Registries, the generation and facilitation of trial/clinical product
transparency activities and deliverables in accordance with relevant
laws, regulations, and policies. In addition, D&T is responsible for
managing the Individual Patient Data Sharing process with qualified
external requestors.

Essential Functions:

Partners with and leads interactions with International Regulatory
Affairs and demonstrates an ability to effectively collaborate
cross-functionally

Oversees compliance and maintain oversight over all Disclosure and
Transparency activities in Countries with mandatory D&T regulations
outside the US

Oversees registration of new protocols, maintenance of protocol
records, and results postings outside of the US

Oversees redaction of clinical trial documents for mandatory
regulations

Serves as a subject matter expert, primary point of contact outside
the US and corporate resource for the D&T group

Trains others on international regulatory and legal clinical trial
disclosure and transparency requirements

Support strategic Disclosures & Transparency initiatives within the
group and cross functionally

Support continuous improvement and ensures processes are efficient,
scalable, and effective

Participates in companywide process improvements and development of
initiatives

Acts as an advisor to various groups on appropriate strategies for
disclosures activities

Demonstrates exceptional operational and organizational skills to
ensure disclosures and transparency activities are performed on time
and with the highest of standards

Evaluates evolving regulations and public guidance on clinical trial
disclosure and data transparency to maintain Company compliance

Participates in group initiatives and authoring of training manuals,
checklist documents, business practices, or standard operating
procedures (SOPs)

Responsible for maintaining and oversight of routine metrics for
reporting to Head of D&T

Supports and Consults with internal core team and/or sub-teams on
strategic transparency initiatives.

Develops and maintains process and system to optimize efficiency,
maximize content reuse and ensure quality.

Knowledge, Experience & Skills:

A BS degree

Knowledge of Global Clinical Trial Transparency and Data Sharing
Requirement preferred.

A well-versed understanding of Regulatory requirements outside the US.

Typically, **Apply on the website**+ years of relevant clinical
development or regulatory affairs experience in the
pharmaceutical/biotechnology development environment (e.g. Sponsor or
Clinical Research Organization (CRO))

Preferably 5 or more years of direct experience in disclosures and/or
data transparency, clinical operations or medical writing/clinical
submissions.

Core understanding and familiarity with Clinical Development, Clinical
Trial conduct, and the Regulatory Submission process is preferred.

Essential:

Experience overseeing clinical trial disclosure activities and
partners with International Regulatory Affairs or Affiliates or local
CROs to ensure new protocol registrations/registration updates and
results postings are released on mandatory clinical trial registries
outside the US in a timely manner.

Has excellent verbal and written communication skills and
interpersonal skills. Can effectively communicate with a variety of
teams and individuals, including team leadership and members of senior
management staff.

For full details and confidential discussion contact Tina at 1 or
email

We need : English (Good)

Type: Permanent
Payment:
Category: Others

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