Associate Director

Job Description

Job Description

Description :

Partners with Safety Board Chair to enable its operational excellence

Provides project management leadership to facilitate TSB processes and activities including escalation and company-wide communication

Ensures training on TSB processes, and continuous improvement by incorporating learnings into ways of working and performance measurement

Functions as Business Process Owner (BPO) for Data Monitoring Committee (DMC), Internal Review Committee (IRC), and First in Human Committee (FiH)

Takes the lead on additional assigned projects to drive organizational goals and operational excellence

Acts as SME overseeing the Reference Safety Information (RSI) CAPA-related activities

Oversees PSPV business continuity plan, monthly department meetings, and PSPV Satori Council

Partners with Global Project Leaders, Global Safety leads, PSPV Therapeutic Areas Heads, and other senior leaders to collect and analyse information supporting the decision-making process to trigger a TSB interaction (e.g. ad hoc Meeting, Milestones Review or Forum)

Collaborates with the TSB Chair, PRC office & PSPV Therapeutic Area Heads to initiate and triage TSB interactions in alignment with established governances and processes (e.g. Other Important Safety Information, Safety Management Team, GLOC, QAM, PCMC).

Oversees logistics and project management of TSB activities

Maintains TSB materials in centralized location, ensuring adequate access to information such as pre-read, meeting minutes, and closeout of all action items

Maintains TSB processes (e.g. SOP, training slides, playbook), and oversees training to ensure understanding of TSB readiness and operating model

Expedites escalation, decision making and communication related to TSB activities.

Analyses and reports TSB performance based on strategic and business goals, working with TSB Chair to measure against Key Performance Indicators (KPIs).

Functions as the Business Process owner for Data Monitoring Committee (DMC), Internal Review Committee (IRC) and First in Human Committee (FiH)

Sets the strategic direction for the process, in coordination with functional experts.

Leads developing, authoring, maintaining & approving procedural document (SOP), operating model RACI, associated templates / forms, training material, technology capabilities.

Liaises with other stakeholders (peer function, quality), ensuring cross-function alignment and escalating issues to sponsors.

Develops global training needs in collaboration with Process, Training and Digital Solutions (PTDS).

As a member of the Strategy and Operations Team, provides input to key strategic & portfolio activities that may include :

Project management support for PSPV initiatives, change-management activities and organization of department meetings.

Supports business analytics and key initiatives enabling operational deliverables aligned with organizations goals.

Supports PSPV business continuity plan and PSPV Satori Council

Foster and maintain an engaging culture and continuously improve PSPV's ways of working.

Acts as SME overseeing the Reference Safety Information (RSI) CAPA-related activities

Qualifications :

Bachelor's Degree Science or business-related field

Advanced degree in science or business is desired

5 years direct experience in the pharmaceutical industry or related field required

Strong organization and project management skills, with ownership of cross functional processes.

Understanding of Pharmacovigilance and impact in the organization.

Proven track-record in working across R&D to support organizational deliverables.

Excellent communication and presentation skills, ability to work with executive leadership.

Ability to collaborate with Team members on cross-functional projects / tasks.

Bachelor's degree in Science or business-related field. Advanced degree preferred.

Previous experience influencing senior-level management and key stakeholders is a plus

Health care business acumen with a comprehensive understanding of the pharmaceutical industry

Demonstrated ability to work across functions, regions, and cultures

Demonstrated leadership with the ability to inspire, motivate and drive results

Excellent communicator, able to persuasively convey both ideas and data, verbally and in writing

Demonstrates leadership presence and confidence across all levels of the organization, including Executive level leaders

Some domestic and international may be required on an infrequent basis

Benefits :

Healthcare Insurance : Synectics offers eligible employees and their dependents healthcare coverage through BlueCross BlueShield of Illinois. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics. Premiums are subsidized by Synectics.

Dental Insurance : Synectics offers eligible employees and their dependents a dental plan through MetLife. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.

Vision Insurance : Synectics offers eligible employees vision insurance through VSP. Eligibility begins on the 1st day of the calendar month following 60 days of continuous full time employment with Synectics.401(k) Plan : The Synectics Inc. Investment Savings Retirement Plan. Synectics offers all employees who are 21 years of age or older the opportunity to invest in the 401(k) Plan on the first enrollment date that is at least 30 days after employment begins. Enrollment dates are each January 1st, April 1st, July 1st, and October 1st.

Technical Certification Bonus : Synectics is pleased to award its employees a bonus of up to $500 for an approved professional certification. In determining the bonus amount, Synectics will consider the cost of the test(s) for any certification relating to your current position, achieved during your employment with us. Only one Certification Bonus per calendar year may be awarded per employee. Only current, active employees will be eligible to receive this bonus. It will be awarded 90 days after the Synectics office has received documentation confirming the successful completion of the certification.

Synectics is an equal opportunity employer.