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

col-narrow-left   

Job ID:

23123

Location:

Cambridge, MA 

Job function:

Business Development, Legal Services, Strategic Planning
col-narrow-right   

Posted:

03.11.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Clinical Systems Strategy Lead (Associate Director)

Job Description:

The Associate Director, TMF Systems provides oversight and governance of the eTMF systems to ensure that the objectives of the TMF information strategy are met. This position will be the pivotal point of contact for all vendor inquiries and for all TMF vendor management activities (e.g. performance management, issue resolution, etc.). This position will use influence, TMF knowledge, and expert project management skills to ensure fulfillment of our vendor relationship and continuous improvement by representing the interests of the TMF team to the vendor. This position will partner closely with the TMF Regulatory Lead to ensure continuous improvement and issue management activities are conducted by the vendor.


Principal Accountabilities

  • Responsible for managing eTMF system with third party vendor and act as the single point-of-contact for all vendor inquiries and for all TMF vendor management activities. Lead resolution of issues and remediation activities with the vendor.
  • Responsible for developing and implementing a strategy to ensure oversight of system compliance, business value and efficiency in the management of the eTMF system.
  • Researches forthcoming technical enhancements/revisions of eTMF system revisions and analyses subsequent impacts to internal processes and technology. Communicates impact with IT and to the wider business functions, and drives execution in collaboration with stakeholders.
  • Represent Biogen at vendor for technical information strategy and influence applicable policies and adoptions of data standards and regulatory technological advancements
  • 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
  • 9 years of experience in Pharmaceutical, Bio-Technology, or Life Sciences
  • Relevant clinical, regulatory and TMF systems experience preferred
  • Experience in interpretation of regulations, guidelines, policy statements, etc.
  • Foster effective, positive interactions with other functions, vendors, and partners
  • Excellent leadership and 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 the world's oldest independent biotechnology company. 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

    Clinical Systems Strategy Lead (Associate Director)

    col-narrow-left   

    Job ID:

    23123

    Location:

    Cambridge, MA 

    Job function:

    Business Development, Legal Services, Strategic Planning
    col-narrow-right   

    Posted:

    03.11.2016

    Employment Type:

    Full time

    Industry:

    Healthcare / Pharma
    col-wide   

    Title:

    Clinical Systems Strategy Lead (Associate Director)

    Job Description:

    The Associate Director, TMF Systems provides oversight and governance of the eTMF systems to ensure that the objectives of the TMF information strategy are met. This position will be the pivotal point of contact for all vendor inquiries and for all TMF vendor management activities (e.g. performance management, issue resolution, etc.). This position will use influence, TMF knowledge, and expert project management skills to ensure fulfillment of our vendor relationship and continuous improvement by representing the interests of the TMF team to the vendor. This position will partner closely with the TMF Regulatory Lead to ensure continuous improvement and issue management activities are conducted by the vendor.


    Principal Accountabilities

  • Responsible for managing eTMF system with third party vendor and act as the single point-of-contact for all vendor inquiries and for all TMF vendor management activities. Lead resolution of issues and remediation activities with the vendor.
  • Responsible for developing and implementing a strategy to ensure oversight of system compliance, business value and efficiency in the management of the eTMF system.
  • Researches forthcoming technical enhancements/revisions of eTMF system revisions and analyses subsequent impacts to internal processes and technology. Communicates impact with IT and to the wider business functions, and drives execution in collaboration with stakeholders.
  • Represent Biogen at vendor for technical information strategy and influence applicable policies and adoptions of data standards and regulatory technological advancements
  • 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
  • 9 years of experience in Pharmaceutical, Bio-Technology, or Life Sciences
  • Relevant clinical, regulatory and TMF systems experience preferred
  • Experience in interpretation of regulations, guidelines, policy statements, etc.
  • Foster effective, positive interactions with other functions, vendors, and partners
  • Excellent leadership and 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 the world's oldest independent biotechnology company. 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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