Lead Associate Publishing Cop Rsmo

vor 2 Wochen

Bern, Schweiz Johnson & Johnson Vollzeit

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

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