X2 Regulatory Clinical Trial Submission Manager

Role Title: X2 Regulatory Clinical Trial Submission Manager 

Location: High wycombe

Work Type: Remote working 

Start Date: As soon as possible

Duration: 31st December 2022

Weekly Hours:  37

Hourly Pay Rate: £70 - £75

This role is inside IR35

The Company:

Johnson & Johnson is the world's most comprehensive and broadly-based healthcare Company, touching the lives of nearly a billion people every day. Our Family of Companies throughout the world compete in consumer, pharmaceutical and medical devices & diagnostics markets and have the skills and resources to tackle the world's most pressing health issues.

Position Summary: 

This position is responsible for managing regulatory Clinical Trial Applications (CTA) submission activities for assigned clinical trials (Phase 1 - Phase 4 spanning six therapeutic areas Oncology, Neuroscience, Cardiovascular and Metabolism, Pulmonary Hypertension, Immunology, and Infectious Diseases).

The Regulatory Clinical Trial Application submission manager has experience in regulatory CTA submission regulations, requirements and will be responsible for the execution of the global CTA submission strategy, as well as the quality and completeness of the CTA regulatory submissions for Clinical Trial Applications, throughout the lifecycle of the trial.

Essential Skills/ Experience

Successful candidates for this position have: in depth regulatory submission experience and regulatory knowledge, project management and leadership skills and strong communication skills.
 

Principal responsibility:

• The Regulatory Clinical Trial Application submission manager will ensure that the required regulatory intelligence is in place to comply with country-specific requirements and will lead a cross-functional team that will compile, publish and produce Clinical Trial Authorization Applications and associated CTA lifecycle submissions (e.g., Health Authority responses, amendments, etc.).
• The CTA submission manager is responsible for interactions with Health Authorities, and will be the primary contact point with regulatory authorities for communications relating to direct submissions of CTAs.
• The CTA submission manager ensures that key events related to the regulatory aspects of clinical trials are tracked in the company-owned tracking system.
• If Clinical Research Organisations are contracted to handle some (or all) aspects as outlined above, the submission manager will be responsible for liaising with and overseeing CRO staff, as required.
  
   

Decision - Making & Problem Solving:

• Identifies and proactively responds to issues, problems, or opportunities as it relates to the leading the CTA workgroup. Independently identifies the need for and collects information (from CTA working groups, GCO, HA-interactions, Local Operating Companies, Regional offices etc.) to better understand and resolve issues/challenges and seize opportunities.
• Integrates information from a variety of sources, detects trends, associations, and cause-effect relationships and communicates to supervisor, CTA working group and others as appropriate.
• Proposes relevant options for addressing problems or opportunities to the supervisor.
• Makes decisions independently for day-to-day activities of CTA workgroup. Decisions as they relate to changing processes that affect external stakeholders require consultation with supervisor and CTA Process Owner.

Independence/ Autonomy:

Works independently to achieve team goals with a high level of autonomy. Routinely updates supervisor on work status and engages supervisor when management support / escalation is required to address issues.

Reporting Relationships:

This function will report to either an Associate Director or Director-level supervisor, within Regulatory Submission Operations Management (RSMO).


 

Working Relationships / Interfaces 

• Regulatory Affairs staff within the global, regional, and    therapeutic area organisations
• Cross-functional CTA working group team members
• Local clinical trials staff
• Health Authorities
• CROs (if applicable)

Required Knowledge, Education, Experience & Communication Skills:

• Bachelor's degree required or equivalent experience; Science degree or related experience with pharmaceutical or health sciences industry is required; knowledgeable with scientific terminology. Ideal candidate would possess a minimum of 4-6 years experience within regulatory affairs in the pharmaceutical industry. An understanding of Drug Development, Clinical Trial Authorization Applications, Regulatory Affairs, and associated legal requirements is also required.
• Must have strong communication skills (written and verbal), as frequent interactions with Health Authorities, Local Operating Companies, GRA, GCO, and teams occur. Must have strong project management skills (e.g. planning, prioritisation, management of schedules and timelines, detail orientation, strong sense of urgency). Ability to lead complex projects and a high degree of problem solving capability required. Must have a high level of Self-Awareness and Adaptability and strong impact and influencing skills.
• Must have demonstrated the ability to lead multi-functional teams and build strong, productive relationships across the organisation. Must be able to work independently, with strong initiative. May have to work remotely from the supervisor.
  
   

Diversity, Equity & Inclusion:

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences

That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.