Sorry, this listing is no longer accepting applications. Don’t worry, we have more awesome opportunities and internships for you.

Construction Laborer

Lexicon Pharmaceuticals, Inc.

Construction Laborer

Basking Ridge, NJ
Full Time
Paid
  • Responsibilities

    Lexicon Pharmaceuticals is currently recruiting for an Executive Director, Regulatory Strategy to develop and lead regulatory strategy for Lexicon’s portfolio of products. This position will be located in the Basking Ridge, New Jersey office. 

     

    JOB SUMMARY:

    The Executive Director, Regulatory Strategy will be accountable for developing and executing the global regulatory strategy for Lexicon’s products.  This individual will be the key interface between Lexicon and regulatory agencies worldwide regarding investigational and marketed products and will collaborate effectively with development partners and vendors to ensure the success of our development projects.  The Executive Director will report to the Senior Vice President of Regulatory Affairs and Quality Assurance, and will work closely with Lexicon’s senior management team, including the Chief Medical Officer, Chief Commercial Officer, and Clinical Operations leader in setting regulatory strategies.  They will be responsible for the management of all regulatory personnel and regulatory activities relating to assigned development stage programs.  He/she This individual will be responsible for ensuring that Lexicon remains in compliance with regulatory obligations.

     

    KEY RESPONSIBILITIES WILL INCLUDE BUT NOT LIMITED TO THE FOLLOWING:

    • Lead a team of regulatory affairs professionals supporting pre-marketing, marketing and post-marketing projects
    • Develop and execute global regulatory strategy for compounds in development starting from pre-IND/IMPD to NDA/MAA submissions and additional claims
    • Plan and lead regulatory health authority meetings and oversee the preparation of meeting requests, meeting packages, participant rehearsals, and summaries/minutes
    • Lead the development and preparation of regulatory documents, with input from subject matter experts and team members. Documents must meet current regulatory standards and must be of high quality, clear, and compelling. These include, but are not limited to IND, Type B or C meeting documents, EOP2, EMA Scientific Advice documents, and NDA/MAA documents prepared in the electronic Common Technical Document (eCTD) format
    • Oversee individuals from Regulatory Affairs who are representing Regulatory Affairs in cross-functional teams responsible for global development programs.
    • Work with internal stakeholders to ensure inquiries from global regulatory agencies and potential issues are addressed in a timely manner.
    • Oversee the development and maintenance of company product labeling documents, Investigator Brochure, including target product profile, company product label, US PI, SMPC.
    • Oversee management of regulatory functional systems, including document management, promotional material management, and regulatory publishing.
    • Oversee company Product Action Committee and other meetings as required
    • Serve as signing member on the Protocol Review committee
    • Manage and participate in post-approval, global product activities. This includes, but may not be limited to, change control, product complaints, supplements and variations leading to labeling updates.
    • Partner with Executive Leadership on the achievement of corporate goals.

    Required Skills Required Experience

    QUALIFICATIONS:

    • Master's, Pharm D, MD, or PhD Degree in Life Sciences or related discipline

    • 15+ years of experience in Pharmaceutical industry, including drug development experience and at least 10 years of experience in leading regulatory teams and participating in cross-functional development teams with demonstrated success in regulatory authority submission strategy, execution, and health authority interaction.

    • Detailed knowledge of FDA/EMA/ICH regulations and guidance for drug development and regulatory policy

    • Experience in developing regulatory strategy for multiple therapeutic area indications and translating into regulatory project plans for key deliverables that integrate with overall development plans

    • Experience in developing and submitting European regulatory documents including Scientific Advice, PIP, pre-MAA and MAA submissions

    • Able to contribute to and critically review regulatory scientific documents across the non-clinical, CMC and clinical disciplines

    • Able to critically evaluate key business/scientific challenges and develop and complete complex, ambiguous initiatives having cross-functional impact

    • Able to articulate a compelling strategic vision to their team that motivates, excites and inspires them to bring their best to Lexicon every day

    • Effectively deploys, allocates and manages resources including outstanding budget management

    • Possesses a high level of attention to detail, excellent verbal and written communication skills, and strong negotiation and influencing skills

    • Able to travel to and from New Jersey and/or Texas and as required to meet with regulatory authorities as needed

    • Experience in all phases of development across multiple therapeutic areas including preparation, submission, and support of INDs, NDAs, and MAAs.

    • Possesses excellent scientific and business judgment; recognized as an internal thought leader with extensive technical and business expertise within a strategic organization

     

    To apply, please visit the careers section of our website: https://lexpharmacareers.silkroad.com/.

     

    For additional information about Lexicon and its programs, please visit www.lexpharma.com.

     

    Lexicon is an Equal Opportunity Employer. We do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, disability or status as a protected veteran.

    _ _

    Lexicon Pharmaceuticals, Inc. is a drug-free workplace. Candidates are required to pass a drug test, background check and verification of credentials before beginning employment.

  • Qualifications

    This position requires the ability to stand for long periods of time, lift a minimum of 50 lbs. Major attributes of the position are punctuality, professionalism within their field and ability to work overtime as needed. 

     

    Consigli is an equal opportunity employer.

    We evaluate qualified applicants without regard to race, color, religion, sex,

    sexual orientation, gender identity, national origin, disability, veteran status, and other protected characteristics.