Principal Transparency and Disclosure Specialist

2 weeks ago

india ProPharma Group Full time

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. As the world’s largest RCO (Research Consulting Organization), ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs.

The Principal Clinical Trial Transparency and Disclosure Specialist position is responsible for the client project management activities and overall coordination, development, and quality oversight of multiple clinical trials disclosure deliverables, including but not limited to compliant registry authoring and maintenance of information on public registries, document redaction, and/or plain language authoring ensuring adherence to relevant industry and client styles and formatting in accordance with all agreed upon timelines.

Essential Functions:

With minimal supervision, acts as primary point of contact for client-related operational activities associated with daily deliverables, managing client expectations along with interacting and communicating directly with clients.

Responsible for the overall compliance and health of the project

Performs/coordinates all activities for the registration, maintenance, and results postings, including document redaction for clinical trials across global registries including Clinicaltrials.gov, EudraCT, and other country-specific registries as applicable.

Ensures development of high-quality registration, maintenance, and results deliverables that are compliant with all applicable policies, procedures, and regulations.

Performs quality assurance review of registry, redaction, and plain language document deliverables, ensuring adherence to all applicable policies, procedures, and regulations, as well as any relevant client styles or guidelines.

Works closely with the internal Client team(s) to ensure understanding of applicable roles and responsibilities related to Client’s disclosure obligations.

Works with the internal Client team(s) to ensure the source information is provided for clinical trials disclosure activities in a timely manner.

Maintains accurate and up-to-date records of individual study activities for timeline integrity, compliance, and relevant metrics tracking.

Sets expectations where necessary and reports on project statuses to medical writing leadership. Makes decisions regarding issue resolution.

Provides frequent and purposeful communication, ensuring all stakeholders are kept informed of progress and updates, as needed, in real time.

Maintains constructive and positive interactions with colleagues.

Provides mentorship and guidance to other team members, as needed.

Develops strong, lasting relationships with client teams that encourage organic new business growth.

Maintains familiarity with current industry practices, regulatory requirements, and guidelines related to clinical trials disclosure and/or data transparency.

Understands budget specifications for assigned deliverables, works within budgeted hours, and communicates out-of-scope tasks to medical writing leadership.

Other duties as assigned.

Necessary Skills and Abilities:

Advanced knowledge, understanding, and application of global clinical trials disclosure guidelines and regulations.

Exceptional project management skills and strong communication skills with a high attention to detail and quality.

Ability to drive projects with conflicting priorities in a matrix team environment, working with individuals from a variety of departments and in a range of countries.

Strong experience in relationship building and strategic collaboration on key business accounts.

Thinks proactively, takes initiative, and willingly takes on new challenges.

Ability to identify areas of concern or inefficiency and propose solutions for consideration by the management team to improve overall efficiency and quality of deliverables.

Works independently with exceptional time management skills and contacts management team proactively when additional support and resources are needed. 

Works effectively in a collaborative team environment. 

Demonstrates a growth mindset and positive outlook in all work activities.

Ability to understand and apply Client guidelines and requirements related to clinical trials disclosure and/or data transparency.

Educational Requirements:

Minimum of bachelor’s degree in related field (scientific field preferred).

Experience Requirements:

Minimum of 8+ years of direct experience in clinical trials disclosure and/or data transparency with a minimum of 2+ years of project management experience.

CRO or Outsourcing experience preferred.

We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

***ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.***

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