Messages In This Digest (4 Messages)
- 1.
- Associate Director Business Strategy - LEO Phama, Parsippany NJ From: Keith Bogen SPHR
- 2.
- Global Regulatory Lead, Early Development (Mgr or Director level) - From: Keith Bogen SPHR
- 3.
- Contract IT Services Role - NYC From: Keith Bogen SPHR
- 4.
- Manager/Senior Manager, Regulatory Affairs (CMC) - Parsippany, NJ From: Keith Bogen SPHR
Messages
- 1.
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Associate Director Business Strategy - LEO Phama, Parsippany NJ
Posted by: "Keith Bogen SPHR" keith.bogen@yahoo.com hrslugger2002
Sat Mar 10, 2012 7:19 pm (PST)
Associate Director Business Strategy
LEO Pharma Inc. is a leading global pharmaceutical company specializing in dermatology and critical care. For 100+ years, our products have improved the quality of millions of people's lives around the world.
Headquartered in Denmark, we have 4500 employees in 50+ countries and our products are sold in more than 100 countries. To realize our vision of becoming the world's leading specialty pharmaceutical company within our focus areas, we are expanding into new regions and markets, reaching more patients and societies with competitive drugs and therapies that address unmet medical needs.
As LEO Pharma expands globally, we are searching for responsible, dedicated and creative people who are passionate about what they do, and who are determined to make a lasting difference to the field in which they operate.
Due to our expansion into the U.S. market, we have an opening for an Associate Director Business Strategy. Reporting into the President of the U.S. Affiliate, this individual contributor will play a pivotal role in project managing all processes related to affiliate strategy, budgeting and forecasting; and ensuring all related deadlines are met. Note: this is not a leadership team position.
Responsibilities:
- Lead the Annual Budget Process (ABP) to ensure that all deadlines are met and all critical business projects and initiatives captured are aligned with the U.S. strategic plan.
- Partner with Finance on Estimates 1 & 2 to ensure all deadlines are met and all critical business projects and initiatives are captured.
- Lead the annual forecasting process for the U.S. affiliate for all current and pre-launch products.
- Partner with Business Development to build the U.S. forecast for potential product acquisitions and New Product Development for pipeline opportunities.
- Manage the strategic calendar for the affiliate and project manage all strategic, budgeting and forecasting processes to ensure deadlines; provide constructive challenge and feedback to functional heads and LT members throughout the processes.
- Work on other projects as assigned by the President.
Requirements:
- BA/BS required; MBA preferred
- 4+ years Sales & Marketing, Commercial Operations or project management experience in the pharma industry or related experience in a pharma agency
- Strong ability to multi-task and manage multiple communication streams
- Consistent and proven track record of delivering results
- Ability to manage tight deadlines and conflict with tact and diplomacy
- Ability to maintain complete confidentiality
- Excel, PowerPoint, Word, Lotus Notes proficiency
- Excellent analytical and strategic skills
- Ability to collaborate and get work done through others using influencing skills.
- Strong administrative skills and organizational skills
- Ability to travel 25% domestically and internationally as required.
Would you like to be part of our success in the U.S.? Please forward resume, cover letter & salary requirements to: Recruitment.US@leo-pharma. (Att: BZS-YG).com
An Equal Opportunity Employer
- 2.
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Global Regulatory Lead, Early Development (Mgr or Director level) -
Posted by: "Keith Bogen SPHR" keith.bogen@yahoo.com hrslugger2002
Sat Mar 10, 2012 7:20 pm (PST)
Global Regulatory Lead, Early Development (Mgr or Director level)
LEO Pharma Inc. is a leading global pharmaceutical company specializing in dermatology and critical care. For 100+ years, our products have improved the quality of millions of people's lives around the world. Headquartered in Denmark, we have employees in 50+ countries and our products are sold in more than 100 countries. To realize our vision of becoming the world's leading specialty pharmaceutical company within our focus areas, we are expanding into new regions and markets, reaching more patients and societies with competitive drugs and therapies that address unmet medical needs.
As LEO Pharma expands globally, we are searching for responsible, dedicated and creative people who are passionate about what they do, and who are determined to make a lasting difference to the field in which they operate.
Due to an expansion into the U.S. market, we have an opening for a Global Regulatory Lead based in our US headquarters in Parsippany, NJ. As part of our Corporate Regulatory Affairs Project department you will be the project leader of a dedicated group of people within Regulatory Affairs responsible for the global regulatory activities of a product in early development. You will be hired at the Manager, Senior Manager, Associate Director or Director level.
You should be an experienced regulatory strategist who has a strong US regulatory background and experience working with early development projects. As part of our Corporate Regulatory Affairs Project department you will be responsible for the overall regulatory goals and regulatory strategies for several of our early development projects. You will be part of a global development team working closely together with cross-functional colleagues in Denmark and Australia as well as external business partners in the US.
In this function you will proactively provide Regulatory pathways and solutions to the early development projects and ensure preparation and communication of the regulatory strategies and risk-assessments. You will be part of creating new ways of working with our early development projects and you will also be involved in our Regulatory Intelligence Platform. You will be responsible for providing status and progress to the Management team of Corporate Regulatory Affairs and R&D Project Management.
Responsibilities:
• Participate in the high level cross functional global development team for early development projects
• Ensure consolidated regulatory strategic plans and risk-assessment
• Ensure that the regulatory strategies are prepared, shared and communicated
• Ensure the overview, timing and prioritization of regulatory activities
• Proactively provide Regulatory Intelligence and Regulatory Advice to the projects
• Lead authority meetings with FDA and other relevant regulatory authorities globally
• Ensure close collaboration with our internal and external partners, consultants and with our regulatory colleagues around the world
• Provide input to business cases in support of strategic decisions to be made by the relevant Decision Boards in R&D
• Provide status and progress to the corporate RA Management on an ongoing basis and prior to each board meeting
• Participate in cross-departmental teams in Regulatory Affairs to secure knowledge sharing
Requirements:
• BA/BS degree in one of the life sciences
• 5-12+ years of Regulatory Affairs experience in the Pharmaceutical/Biotechnology industry
• Solid knowledge of US regulations
• Experience with driving and leading projects
• Experience working with the FDA
• Experience working globally is preferred
• Experience with electronic submissions (eCTD)
• Excellent communication skills (verbal and written)
• The ability and willingness to travel internationally (mainly Europe and Australia) up to 20%
• Creative problem solver
Would you like to be part of LEO's growth in the US? Please forward resume, cover letter & salary requirements to: Recruitment.US@leo-pharma. (Att: MM-YG).com
Equal Opportunity Employer
- 3.
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Contract IT Services Role - NYC
Posted by: "Keith Bogen SPHR" keith.bogen@yahoo.com hrslugger2002
Sat Mar 10, 2012 7:24 pm (PST)
Would you know anyone that I can speak to for this position, it is a contract , ONLY, paying $65-68 per hour in NYC long term at least 12 months, and downtown.
Sourcing experience and expertise including knowledge of the following categories in the IT professional services space including:
• Application and Web Hosting Services
• Software Development, Maintenance and Support Services
• Business Process Outsourcing Services
• IT Strategy Development and Architecture Services
MINIMUM YEARS OF EXPERIENCE:
• 10+ years experience running IT strategic sourcing processes and related disciplines (e.g., RFx development and execution, targeted negotiations, project management, etc.)
• 7+ years experience drafting, negotiating and executing highly effective IT contracts
• Expertise in vendor management, consensus building, teamwork and relationship management
• Technical/vendor expertise for managed commodities
• Extremely strong financial and analytical skills with the capability to build, analyze and present highly complex financial and pricing models
• Strong MS Office Productivity skills (including Excel, Word and PowerPoint)
Let DTG help you to attract and retain the best talent!
Diane Havelock
Senior Account Executive
DTG Consulting Solutions
253 West 35th Street
diane.havelock@dtg-usa.com
D: 212-629-7719
BB: 917-453-0137 (best reach)
www.dtg-usa.com
http://www.linkedin.com/in/dhaveloc k
New York, NY 10001
- 4.
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Manager/Senior Manager, Regulatory Affairs (CMC) - Parsippany, NJ
Posted by: "Keith Bogen SPHR" keith.bogen@yahoo.com hrslugger2002
Sat Mar 10, 2012 7:47 pm (PST)
Manager/Senior Manager, Regulatory Affairs (CMC)
LEO Pharma Inc. is a leading global pharmaceutical company specializing in dermatology and critical care. For 100+ years, our products have improved the quality of millions of people's lives around the world.
Headquartered in Denmark, we have employees in 50+ countries and our products are sold in more than 100 countries. To realize our vision of becoming the world's leading specialty pharmaceutical company within our focus areas, we are expanding into new regions and markets, reaching more patients and societies with competitive drugs and therapies that address unmet medical needs.
As LEO Pharma expands globally, we are searching for responsible, dedicated and creative people who are passionate about what they do, and who are determined to make a lasting difference to the field in which they operate.
Due to an expansion into the U.S. market, we are searching for a Manager/Senior Manager, Regulatory Affairs who will manage the CMC aspects of U.S. Regulatory Affairs for multiple commercial and clinical projects. This position is also responsible for interpreting U.S. FDA (CMC) regulations and guidances and providing regulatory advice to applicable LEO team members. They will also be responsible for preparation of CMC submissions within established timelines. The Manager will directly interact with U.S. FDA to ensure acceptance, rapid review, and approval of NDAs, supplements, and other filings which present CMC information. This role requires a well-rounded knowledge of FDA drug regulations and experience in all aspects of the regulatory function.
Responsibilities:
• Review and edit CMC documentation to ensure that required documents are generated according to agreed upon timelines and U.S. FDA regulatory requirements
• Assemble, coordinate and compile the required CMC technical documents needed to complete NDA, sNDA, and other U.S. filings including mandatory submissions such as IND/NDA Annual Reports
• Prepare responses to technical questions raised by US FDA
• Represent US Regulatory Affairs on global technical project teams providing CMC regulatory strategy and filing requirements
• Coordinate responses to regulatory questions in a timely manner, while reviewing manufacturing data submitted in support of new products and supplemental applications
• Responsible for regulatory communications with Corporate Regulatory Affairs related to CMC components of product approvals and maintaining approval status world wide
• Ensure regulatory compliance by participating in global and US change control processes
• Author company's or department's SOPs addressing regulated processes as appropriate
• Provide input into strategic planning to achieve global, regional or departmental goals for development project approval and life-cycle management
• Maintain local and global cross-functional coordination to meet post-approval commitments
• Provide regulatory input in due diligence proceedings with regards to manufacturing documentation and submissions
• Act as back-up Regulatory reviewer of promotional materials and assist with DDMAC submissions and provide support for other FDA submissions as necessary
• Evaluates and approves proposed changes to products and processes; develops, approves and implements U.S. regulatory plans based on these changes
• Plan and conduct internal audits, facilitates customer audits and audits by the U.S. and International regulatory agencies
• Assists with LEO policy and procedure development & implementation in alignment with HQ policies.
• Make routine decisions and as appropriate raise situations/trends to Management; expected to make recommendations for situation/trend identified
• Assists with agency audits by compiling and reviewing data that is to be presented to investigator or possible scribe capturing conversations between agency and LEO personnel
Requirements:
• BA/BS degree in one of the life sciences
• 5 or more years of experience gained working in the Pharmaceutical/Biotechnology industry
• Several years of direct regulatory affairs experience including CMC
• Experience developing and enhancing regulatory related SOPs
• Excellent communication skills (verbal and writing skills)
• Creative thinking
• The ability and willingness to travel domestically and internationally as required
Would you like to be part of our success in the US? Please forward resume, cover letter & salary requirements to: Recruitment.US@leo-pharma. (Att: RA-YG). An Equal Opportunity Employercom
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