Pharmaceutical Delivery Manager at Yoh in Gaithersburg, Maryland

Job Description:

We have an immediate contract opportunity for a Global Delivery Manager with Yoh's client located in Gaithersburg Maryland. This position is approved for 1 year and could be extended.

Pay Rate: $45/Hr.

THE BIG PICTURE - TOP SKILLS SHOULD YOU POSSESS:

* The Global Labeling Delivery Manager is responsible for document management of EU and US labeling for assigned marketed and/or pipeline products.

* This includes delivering high-quality, submission ready documents according to required timelines, managing the EU linguistic review process and authoring content of labeling for US SPL submissions.

* Pharmaceutical experience

* Preferably regulatory experience working with labeling

* Knowledge of labeling regulations and guidances

WHAT YOU'LL BE DOING:

* Ensure all work is performed in accordance with procedures, regulatory requirements and GxPs.

* Provide support to Global Labeling Strategist with regards to labeling documents for submission

* Provide guidance to regarding regulatory technical requirements for regional labeling submissions

* Manage labeling submissions for US and EU, including QC, proofing, copy editing and formatting of documents, and coordinate review and approval of final submission documents

* Understand industry labeling trends related to labeling and submission guidance and directives

* Interpret regional labeling regulations and guidance, determining company impact and providing comments as appropriate

* Liase with Global Labeling Strategy and RPM to advise/recommend submission best practices

* Contribute the regulatory labeling perspective in support of submission delivery

* At the request of Labeling Strategist, originate precedent searches, create and maintain labeling comparisons

* Interact with Marketing Company colleagues regarding linguistic review and translations

* Oversee and coordinate EU linguistic review process as appropriate

* Interact with appropriate functional groups to obtain labeling annotations and supporting documentation

* Author Content of Labeling/Drug Listing SPL file

* Generate and validate SPL file for submission

* Draft summaries of labeling changes for PSURs, Annual Reports and other periodic reports

* Maintain labeling lifecycle of documents and ensure proper naming according to DNC

* Coordinate with Regional Regulatory staff to deliver submission ready documents and ensure submission timelines are met

* Assist in responding to labeling-related queries from various functional areas

* Assist Global Labeling team in resolution of labeling issues as needed

* Participate in the development and maintenance of work practices, templates, and associated documents relating to the labeling function

* Liaise with senior management as needed to resolve critical labeling issues

* Represent functional expertise at relevant department meetings and relevant cross functional subteams Education, Qualifications, Skills and Experience Essential Desirable

WHAT YOU NEED TO BRING TO THE TABLE:

* Keen attention to detail and accuracy

* Excellent verbal and written communication skills

* Multi-cultural awareness and sensitivity; demonstrated experience effectively communicating and negotiating in diverse cultures.

* Ability to think strategically, appropriately assess risks and formulate strategies to manage risk

* Building Relationships (works well across formal and informal networks)

* Negotiation Skills (good listener; able to build a consensus)

* Critical Information Seeking (works well across formal and informal networks)

* Rational Persuasion (able to distil an issue to its key components and suggest solutions)

* Interpersonal Awareness (aware of how actions affect other people)

* Experience in packaging labeling development and/or maintenance

EDUCATION:

University Degree in Science or related discipline

OPPORTUNITY IS CALLING, APPLY NOW!

RECRUITER: CHRIS AIELLO

Yoh makes finding and applying for jobs simple. Partner with Yoh to find the right opportunities across multiple industries in the US and UK. Find out more here!

#ZipESD

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer, M/F/D/V. Click here:
http://www.yoh.com/applicants-with-disabilities
to contact us if you are an individual with a disability and require accommodation in the application process.

Apply Now