Lead Associate Publishing Cop Rsmo

4 days ago

High Wycombe, United Kingdom Johnson & Johnson Full time

In this role you will:

- Use regulatory information management systems and tools to assemble, publish, validate, dispatch, and archive complex submissions according to internal processes and regulatory guidelines for paper and electronic submissions with a high degree of independence.
- Where appropriate, provide component-level publishing support for regulatory-owned deliverables in PDF format to ensure dossier components conform to submission standards (e.g., bookmarking, linking, PDF version, etc.).
- Maintain open, timely, and effective communications with all publishing contributors and responsible regulatory affairs professionals to ensure timely delivery of submission components and/or complete submissions to release for dispatch to a health authority or distribution to a local operating company.
- Proactively interact and support RSMO and cross-functional partners for submission-related needs and issues, as required.
- Proactively provide technical training and/or guidance to submission contributors on submission requirements, standards, and processes to facilitate efficient processing by regulatory agencies.
- Figures out scope of the electronic publishing requirements for the submission.
- Identify and drive business improvement opportunities to streamline and align global submission processes, where possible, across the organization, with a focus on quality, compliance, and efficiencies.
- Lead multiple high complexity submissions simultaneously with a high degree of independence.
- Interprets and implements paper and electronic regulatory submission standards, policies, and operating procedure requirements.
- Consult with various departments regarding submission requirements and standards to facilitate efficient processing by agencies.
- Cultivate ongoing effective relationships within GRA as well as cross-functionally. Works with partners to communicate and resolve issues/concerns with submission timelines.

In this role you may:

- Create and lead Dossier Plans/Submission Packages in line with regulatory strategy, seeking input from regulatory therapeutic areas, functional area representatives, and key stakeholders, while providing guidance to project team members.
- Use regulatory information management systems and tools to assemble, publish, validate, dispatch, and archive complex submissions according to internal processes and regulatory guidelines for paper and electronic submissions with a high degree of independence.
- Cultivate ongoing effective relationships across GRA as well as cross-functionally. Maintains open communications with key partners to communicate and resolve issues/concerns with submission timelines.
- Handle multiple high complexity submissions simultaneously with a high-degree of independence.
- Perform a dossier review of the published output.
- Lead Submission Team meetings to coordinates the preparation and maintenance of regulatory submissions and filings.
- Monitor the effectiveness of the submission process and initiate changes within the scope of decision-making authority to minimize inefficiencies and ensure / improve quality.
- May lead and/or participate in special projects and process improvements, and associated training material.

**Qualifications** Qualifications**

**Education**:

- University/Bachelor’s degree or equivalent experience and a minimum of 5 years of pharmaceutical industry or related experience.
- Masters/Pharm D/PhD with 1-3 years of experience

**Experience and Skills**:

- Experience associated with publishing submissions for global Marketing Applications (e.g., NDA/BLA/MAA/NDS) and related lifecycle is required
- Experience associated with planning of lifecycle Market and Registration submissions (e.g., NDA/BLA/MAA/NDS) is required
- Experience publishing/planning Marketing Applications for emerging markets (ie: AsiaPac LATAM, Middle East/Africa, etc.) is highly preferred
- Experience of coordinating and compiling submissions using publishing technologies, submission portals, and document management systems
- In-depth understanding of drug development process is required
- Demonstrated project or submission management capabilities is highly preferred
- Previous experience leading Submission Team meetings to coordinate the preparation and maintenance of regulatory submissions and filings is highly preferred
- Ability to work in a matrix environment required
- Proven ability to build productive relationships and influence partners across an organization required
- Knowledge of relevant submission-related Health Authority and Industry regulations and guidelines is required
- Ability to use Regulatory Information systems required

**Other**:
This position may require up to 5% domestic and international travel.

Johnson & Johnson Family of Companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genet

  • Head of Regulatory Publishing Solutions

    16 hours ago

    High Wycombe, Buckinghamshire, United Kingdom Johnson & Johnson Full time

    Johnson & Johnson Innovative Medicine is recruiting for an experienced Associate Director to join our team as Head of Regulatory Publishing Solutions. This role involves leading cross-functional initiatives to improve efficiency and compliance in regulatory submissions.About the TeamYou will be part of a dynamic team that works collaboratively to support...

  • Document Publishing Solutions Director

    1 day ago

    High Wycombe, Buckinghamshire, United Kingdom Gated Talent Full time

    Job OverviewWe are seeking an experienced professional to lead our Document Publishing Solutions team at Gated Talent. This role involves overseeing the quality of deliverables, ensuring compliance with regulatory submissions, and driving decisions impacting document processing.

  • Regulatory Submission Operations Lead

    11 hours ago

    High Wycombe, Buckinghamshire, United Kingdom Gated Talent Full time

    About the RoleThe Clinical Document Management Specialist will be responsible for establishing guidelines and standards for document preparation, review, and approval. This includes ensuring adherence to all quality and submission standards, as well as partnering with cross-functional teams to support proper development of electronic publishing practices.The...

  • Clinical Research Associate Lead

    5 days ago

    High Wycombe, Buckinghamshire, United Kingdom Disability Solutions Full time

    Job Description: Clinical Research Associate LeadWe are looking for a skilled Clinical Research Associate Lead to lead our clinical research team. The ideal candidate will have experience in managing clinical trials in phases 2-4 and will be knowledgeable in regulatory requirements, SOPs, and GCP.The successful candidate will be responsible for implementing...

  • Scientific Knowledge Management Associate

    7 months ago

    High Wycombe, United Kingdom Clinical Professionals Full time

    **Reference Number: JO-2201-484262** Scientific Knowledge Management Associate Rate: Negotiable **Job Type**: Contract Location: High Wycombe Scientific knowledge management (SKM) associate Contact till the end of 2021 High Wycombe based office requirement 3 or 4 days per week PAYE - £30.20 - To provide operational and administrative support to members...

  • Customer Engagement Product Lead

    3 weeks ago

    High Wycombe, Buckinghamshire, United Kingdom FJWilson Talent Services Full time

    Key ResponsibilitiesAs a Customer Engagement Product Lead, you will be responsible for building expert knowledge of our web CMS platforms, supporting content creation, analytics, and optimal publishing processes.You will provide training on CMS platforms, SEO best practices, and ad-hoc support for content teams, ensuring the technologies align with evolving...

  • Director of Pharmaceutical Document Operations

    14 hours ago

    High Wycombe, Buckinghamshire, United Kingdom Johnson & Johnson Full time

    We are seeking a talented Associate Director to lead our Document Publishing Solutions (DPS) function. As a key member of our team, you will be responsible for driving strategic direction and decision-making processes within the DPS function.About the RoleYou will work closely with cross-pharma R&D groups to provide support and process improvements, ensuring...

  • Web Platforms Delivery Lead

    3 weeks ago

    High Wycombe, Buckinghamshire, United Kingdom FJWilson Talent Services Full time £52,000

    About the JobAs a Web Platforms Delivery Lead, you will be responsible for ensuring our web platforms deliver outstanding functionality and a seamless customer experience, supporting current needs while driving continuous improvements. You will research, plan, and deliver a strategic roadmap to enhance online customer engagement, Collaborate with internal...

  • Associate Dental Specialist

    2 weeks ago

    High Wycombe, Buckinghamshire, United Kingdom Rodericks Dental Partners Full time

    Job DescriptionWe are seeking an Associate Dentist to join our clinical team. As an Associate Dentist, you will play a leading role in delivering high-quality care to patients and contribute to the growth and success of our practice.Deliver exceptional patient careCollaborate with colleagues to achieve clinical goalsContribute to the development of clinical...

  • Mental Health Teaching Associate

    2 weeks ago

    High Wycombe, Buckinghamshire, United Kingdom Academics Ltd Full time

    **About the Role:** Mental Health Teaching AssociateAcademics Ltd is seeking a qualified and experienced Mental Health Teaching Associate to join our team. As a Mental Health Teaching Associate, you will play a vital role in supporting students with mental health challenges to access their learning and development.You will work closely with teachers and...

  • Web Experience Product Lead

    2 weeks ago

    High Wycombe, Buckinghamshire, United Kingdom FJWilson Talent Services Full time £52,000

    Job Description:FJWilson Talent Services is seeking a highly skilled Web Experience Product Lead to join our team. As a key member of our digital delivery management team, you will be responsible for ensuring our web platforms deliver exceptional user experiences. In this role, you will collaborate with internal and external development teams using...

  • Primary School Teaching Associate

    3 weeks ago

    High Wycombe, Buckinghamshire, United Kingdom Academics Full time

    Primary School Teaching AssociateWe are looking for a Primary School Teaching Associate to join our team at Academics in High Wycombe.In this role, you will lead classes, develop children's skills in learning, and cover classes during teacher absences using teaching plans to ensure continued student progress.The ideal candidate will have a passion for...

  • Partner Track Associate

    2 weeks ago

    High Wycombe, Buckinghamshire, United Kingdom Errington Legal Full time

    A highly experienced Senior Associate is required to join our IP/Comm Tech team in Oxford as a Partner Track candidate.Key responsibilities will include leading client matters, building independent relationships, and driving business growth.In return, you'll enjoy a competitive salary, generous holidays, and access to private healthcare.For further details,...

  • Senior Commercial Associate

    7 days ago

    High Wycombe, Buckinghamshire, United Kingdom Errington Legal Full time

    At Errington Legal, we are seeking a highly experienced Senior Associate to join our IP/Comm Tech team in Oxford. With a minimum of 8 years of post-qualification experience (PQE), this role is ideal for an individual with a proven track record of leading client matters and building independent relationships.We offer a competitive salary of around £120,000...

  • Goods Receipt and Packing Associate

    5 days ago

    High Wycombe, Buckinghamshire, United Kingdom Veolia Water Technologies Full time

    Goods Receipt and Packing AssociateWe are seeking a reliable and efficient Goods Receipt and Packing Associate to join our team at ELGA LabWater's manufacturing facility in Cressex.In this role, you will be responsible for receiving components, checking deliveries, and preparing finished goods for dispatch.The successful candidate will have excellent...

  • Technical Help Desk Associate

    12 hours ago

    High Wycombe, Buckinghamshire, United Kingdom Austin Fraser Full time

    Austin Fraser seeks an experienced Technical Help Desk Associate to join our team. This role comes with a salary of £32,000 - £40,000 per annum, plus benefits.The ideal candidate will have full, clean UK driving licence and basic electronics knowledge. You will be responsible for acting as the first point of contact for customers, providing technical...

  • Financial Planning Lead

    8 hours ago

    High Wycombe, United Kingdom Robertson Bell Full time

    Are you seeking an FP&A focused role? Could you lead on the production of a large and complex group long-term financial plan? Are you keen to secure a role that will offer you staff management responsibilities? If yes, keep reading! Robertson Bell are partnering with this brilliant and forward-thinking housing association whilst they recruit for a Financial...

  • Risk Management Lead

    3 weeks ago

    High Wycombe, United Kingdom The Collective Network Limited Full time

    Risk Management LeadWe are seeking an experienced Risk Management Lead to join our team at The Collective Network Limited. As a key member of our staff, you will play a vital role in identifying and mitigating risks associated with our global operations.Working closely with our senior leadership team, you will develop and implement strategies to capitalize...

  • Emea Medical Program Associate

    6 days ago

    High Wycombe, United Kingdom CK GROUP Full time

    CK Group are recruiting for EMEA Medical Program Associate to join a company in the Pharmaceutical industry at their site based in High Wycombe initially on a contract basis for 6 months with very strong potential to be further extended. **Salary**: Per Hour £52.72 (LTD) / £44.67 (PAYE) - Outside IR35 **Company**: Our client is the largest and most...

  • Restaurant Operations Associate

    15 hours ago

    High Wycombe, Buckinghamshire, United Kingdom Trafalgar Entertainment Group Limited Full time

    Are you passionate about delivering exceptional dining experiences? Do you have a keen eye for detail and a commitment to excellence? If so, we invite you to apply for the Restaurant Operations Associate role at Trafalgar Entertainment Group Limited.In this critical position, you'll contribute to maintaining the highest standards of cleanliness and...