Senior Submissions Specialist

Senior Submissions Specialist

Location: High Wycombe

Working mode: Hybrid, 3 days on-site and 2 WFH

Duration: Until the end of 2024

Hours: 37 hours per week

Pay rate range: Competitive hourly rate (PAYE and Umbrella options available)

Imagine your next project as Senior Submissions Specialist. The post holder will be responsible for accurate and timely query management (set-up, maintenance, and oversight). This includes retrospective review and understanding and interpretation of the Regulatory Reporting Requirements. Provides guidance and oversight to junior team members. Takes the lead and acts as Subject Matter Expert (SME) on key initiatives and functional activities.

roles and responsibilities

• Acts a delegate to more senior staff in the team upon request

• Supervises activities performed by more junior members of staff and performs peer review as required

• Plays a key role in team meetings and daily liaison with team members to identify and resolve processing issues

• Provide guidance and support to clarify procedures (e.g. training) to ensure compliance relating to SR collaboration with business partners, European Medicines Agency (EMA), Regulatory Authorities (RAs), Local Safety Officers (LSOs), Pharmacovigilance (PV) nominated person and other groups such as Global Clinical Organization (GCO), licensing partners and Regulatory Affairs (RA)

Takes the lead or acts as SME when requested in one or more of the below activities:

1. Regulatory intelligence

2. Quality monitoring activities

3. Process/system improvement

4. Global Safety Reporting initiatives such as regulation changes

5. Compliance and quality metrics preparation for Global Safety Reporting

6. Controlled document creation/update

7. Pharmacovigilance Agreement (PVA) review and implementation

8. Quality Investigations and CAPA activities

• Prepares training material and delivers training

• On the job training and mentoring of staff as required

Operational Activities

• Performs duties as per the rota such as daily /weekly checks and report reviews

• Responsible for distribution rule -set up for maintenance and updates changes and maintenance in the Global Safety Reporting system Outbound System Tracking (OST)

• Oversees distribution rule -set up performed by team members and when required, performs rule set up, changes and maintenance in OST. for Global Safety Reporting

• Review Individual Case Safety Reports (ICSRs) within Global Safety Reporting scope of responsibility for reportability based on Standard Operating Procedures (SOPs), Work Instructions and internal guidance documents

• Triaging and prioritization of ICSRs for regulatory reporting by following the business rules and SOPs

• Perform review submissions review and no submit review

• Responsible for daily manual or electronic submission of ICSRs to Health Authorities and Business Partners

• Record, track and monitor successful transmission in OST

• Produce CIOMS/Medwatch and fax/email, distribute, and upload to document storage

• Handles delegations (interactions with Local Safety Officers (LSOs) who delegate regulatory reporting to Global Medical Safety Operations (GMSO)

• Identifies and develops solutions for areas needing improvement and considers the use of technology for the automation of process steps

• Take a leading role in providing input and supporting authoring consistent processes that meet both internal and regulatory standards to meet global requirements

• Identifies and actions any gaps or inaccuracies in controlled documents relevant for performing safety reporting activities, business continuity and audit/inspection readiness

• Acts a delegate to more Manager/Director in relation to Submission activities and distribution rule set up and maintenance

• Takes lead on projects such as Bi Annual review

• Participates in oversight activities with the Marketing Authorization Holder (MAH)

• Liaise with other functions for resolution of queries and issues

• Identifies and resolves issues or prepares documentation and options for solution where escalation is required

• Participate in User Acceptance Testing (UAT) for upgrade / enhancements to safety systems including support of script writing

• Prepares agendas, facilitates team meetings and takes minutes.

• Is responsible for impact assessments and bolus management activities

• Investigate, document and track compliance related data

• Participates as SME in Audit and Inspection and assists in preparation of document requests

• Provides support for holiday cover according to the Business continuity plan

how to succeed

• Degree and/or relevant work experience

• Good Understanding of US and EU regulatory reporting requirements for ICSRs

• Good computer skills

• Knowledge of regional and global safety regulations

• Good understanding of Case Reporting application and familiarity with query logic

• Sense of urgency (timelines)

• Strong attention to detail

• Good organizational and communication skills including presentation abilities

• Ability to problem solve

• Proactive approach

benefits

This role offers a very competitive hourly rate. This contract will run until the end of 2024.

you are welcome here

Johnson & Johnson Innovative Medicine is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson Innovative Medicine

Patients inform and inspire our science-based innovations, which continue to change and save lives. Applying rigorous science and compassion, we confidently address some of the most complex diseases of our time and unlock the potential medicines of tomorrow.

Our diverse portfolio spans multiple therapeutic areas — Oncology, Immunology, Neuroscience, Cardiovascular, Pulmonary Hypertension, and Retina.

We are continuously working to develop treatments, aspiring to find cures, pioneering the path from lab to life, and championing patients every step of the way.

Janssen UK: https://www.janssen.com/uk/

Janssen Ireland: https://www.janssen.com/ireland/

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. The pay rate for this role will depend on how you are paid. PAYE & Umbrella options are available. 

questions

If you would like some additional information about the role please contact: sara.marsalo@randstadsourceright.co.uk (please note that we do not accept applications via email)

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”.