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Regulatory Systems Strategy Lead (Associate Director/Director). Job in Cambridge, Massachusetts, United States in Biogen. Nelest.com
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Regulatory Systems Strategy Lead (Associate Director/Director)

col-narrow-left   

Job ID:

23118

Location:

Cambridge, MA 

Job function:

Information Systems Management
col-narrow-right   

Posted:

03.11.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Regulatory Systems Strategy Lead (Associate Director/Director)

Job Description:

The Head of Regulatory System Strategy drives how the regulatory function brings together its technology, processes and people to enable strategic objectives and underpin Regulatory core capabilities. Develops and implements the Regulatory Information Strategy in line with broader organization objectives. Provides oversight and governance of Regulatory systems, business processes and compliant usage to ensure that the objectives of the regulatory information strategy are met.
Responsible for analyzing Regulatory IT/technology industry trends and driving best practices across Regulatory and cross functional interfaces.
Partner with IT, Business functions and Project Management Office to provide holistic strategy of Regulatory Systems integration, as well as with vendor(s) to influence HA and industry innovation.


Main Responsibilities Include:
  • Responsible for developing & evolving the regulatory information strategy in line with regulatory affairs & affected stakeholders, including industry and Health Authority perspectives, to ensure robust future proof processes and systems.
  • Responsible for overseeing regulatory information quality, reporting and analytics to monitor quality and maximize the use of regulatory information. Includes interface data that is required between different cross functional systems and drives the integration of data and processes from a system perspective
  • Responsible for developing and implementing a strategy to ensure oversight of system compliance, business value and efficiency in the management and delivery of regulatory information services, leveraging appropriate vendor partnerships.
  • Represent Biogen at HA/Industry body meetings for regulatory information strategy and influence applicable policies and adoptions of data standards and regulatory technological advancements
  • Researches forthcoming regulatory guidance revisions and analyses subsequent impacts to internal processes & technology. Communicates impacts to wider business functions, and drives execution in collaboration with stakeholders.
  • Effectively communicates project status, issues, schedule and accomplishments to regulatory affairs and stakeholder groups, as needed.
  • Ensures regulatory information strategy is communicated and understood by broader cross functional teams.


    *LI-RD1
  • Job Requirements:

    Qualifications
  • 10+ years of experience in Pharmaceutical, Bio-Technology, or Life Sciences
  • Minimum of 5 years in regulatory operations or similar
  • Leadership experience in implementing innovative systems
  • Leadership role in Regulatory information management/GxP data
  • Highly developed Stakeholder Management skills
  • Strong communication and influencing skills
  • Education
  • Bachelor's Degree Life Sciences/Business/IT
  • If Life Sciences degree further advanced qualification in business/IT preferred
  • About BiogenBiogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies to improve the lives of patients with neurodegenerative diseases, hematologic conditions and autoimmune diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia.

    Founded in 1978, Biogen is one of the world's oldest biotechnology companies. Our development pipeline is focused on areas of high unmet medical need, as we pursue new therapies for patients suffering from diseases with few or no treatment options. These include programs for secondary progressive MS, Alzheimer's Disease, spinal muscular atrophy, lupus and amyotrophic lateral sclerosis (ALS), amongst others.

    With approximately 7,500 people worldwide, Biogen is truly a global organization. We are headquartered in Cambridge, Massachusetts, which is home to our research operations. Our international operations are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.

    Please be advised that all legitimate correspondence from a Biogen employee will come from '@biogen.com' or '@biogenidec.com' email accounts.

    Zip Code:

    02142

    Company Info
    Biogen

    Cambridge, MA, United States

    Phone: +1 781-464-3260, +1 781-464-3260
    Web Site: www.biogene.com

    Company Profile

    Company Info


    Biogen
    Cambridge, MA, United States
    Phone: +1 781-464-3260, +1 781-464-3260
    Web Site: www.biogene.com

    Regulatory Systems Strategy Lead (Associate Director/Director)

    col-narrow-left   

    Job ID:

    23118

    Location:

    Cambridge, MA 

    Job function:

    Information Systems Management
    col-narrow-right   

    Posted:

    03.11.2016

    Employment Type:

    Full time

    Industry:

    Healthcare / Pharma
    col-wide   

    Title:

    Regulatory Systems Strategy Lead (Associate Director/Director)

    Job Description:

    The Head of Regulatory System Strategy drives how the regulatory function brings together its technology, processes and people to enable strategic objectives and underpin Regulatory core capabilities. Develops and implements the Regulatory Information Strategy in line with broader organization objectives. Provides oversight and governance of Regulatory systems, business processes and compliant usage to ensure that the objectives of the regulatory information strategy are met.
    Responsible for analyzing Regulatory IT/technology industry trends and driving best practices across Regulatory and cross functional interfaces.
    Partner with IT, Business functions and Project Management Office to provide holistic strategy of Regulatory Systems integration, as well as with vendor(s) to influence HA and industry innovation.


    Main Responsibilities Include:
  • Responsible for developing & evolving the regulatory information strategy in line with regulatory affairs & affected stakeholders, including industry and Health Authority perspectives, to ensure robust future proof processes and systems.
  • Responsible for overseeing regulatory information quality, reporting and analytics to monitor quality and maximize the use of regulatory information. Includes interface data that is required between different cross functional systems and drives the integration of data and processes from a system perspective
  • Responsible for developing and implementing a strategy to ensure oversight of system compliance, business value and efficiency in the management and delivery of regulatory information services, leveraging appropriate vendor partnerships.
  • Represent Biogen at HA/Industry body meetings for regulatory information strategy and influence applicable policies and adoptions of data standards and regulatory technological advancements
  • Researches forthcoming regulatory guidance revisions and analyses subsequent impacts to internal processes & technology. Communicates impacts to wider business functions, and drives execution in collaboration with stakeholders.
  • Effectively communicates project status, issues, schedule and accomplishments to regulatory affairs and stakeholder groups, as needed.
  • Ensures regulatory information strategy is communicated and understood by broader cross functional teams.


    *LI-RD1
  • Job Requirements:

    Qualifications
  • 10+ years of experience in Pharmaceutical, Bio-Technology, or Life Sciences
  • Minimum of 5 years in regulatory operations or similar
  • Leadership experience in implementing innovative systems
  • Leadership role in Regulatory information management/GxP data
  • Highly developed Stakeholder Management skills
  • Strong communication and influencing skills
  • Education
  • Bachelor's Degree Life Sciences/Business/IT
  • If Life Sciences degree further advanced qualification in business/IT preferred
  • About BiogenBiogen (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers innovative therapies to improve the lives of patients with neurodegenerative diseases, hematologic conditions and autoimmune diseases. Patients worldwide benefit every day from our medicines for multiple sclerosis (MS) and hemophilia.

    Founded in 1978, Biogen is one of the world's oldest biotechnology companies. Our development pipeline is focused on areas of high unmet medical need, as we pursue new therapies for patients suffering from diseases with few or no treatment options. These include programs for secondary progressive MS, Alzheimer's Disease, spinal muscular atrophy, lupus and amyotrophic lateral sclerosis (ALS), amongst others.

    With approximately 7,500 people worldwide, Biogen is truly a global organization. We are headquartered in Cambridge, Massachusetts, which is home to our research operations. Our international operations are based in Zug, Switzerland and we have world-class manufacturing facilities in North Carolina and Denmark. We offer therapies globally through direct affiliate presence in 30 countries and a network of distribution partners in over 50 additional countries.

    All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, disability or protected veteran status.

    Please be advised that all legitimate correspondence from a Biogen employee will come from '@biogen.com' or '@biogenidec.com' email accounts.

    Zip Code:

    02142
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