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Director, Commercial Regulatory Affairs. Job in Cambridge, Massachusetts, United States in Biogen. Nelest.com
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Director, Commercial Regulatory Affairs

col-narrow-left   

Job ID:

23121

Location:

Cambridge, MA 

Job function:

Business Development, Legal Services
col-narrow-right   

Posted:

03.11.2016

Employment Type:

Full time

Industry:

Healthcare / Pharma
col-wide   

Title:

Director, Commercial Regulatory Affairs

Job Description:

Position Summary


Responsible for strategic development and risk assessment of activities in support of external commercial communications. This individual interprets and integrates overall business objectives into departmental and team goals. The Director acts as an integral member of cross-functional teams that establish strategy and vision for promotional materials including patient materials, sales training materials, press materials, and other external communications. Within cross functional teams, this person establishes regulatory strategy for developing draft labeling for regulatory authority review and approval and, after approval, for maintaining labeling documents. This individual represents regulatory affairs within Biogen and externally. This individual has the ability to influence professional organizations and Biogen colleagues at all levels. The Director, ALP should demonstrate strong communication skills, effective cross-functional and cross-cultural skills, with a proficiency strategic business thinking.


Duties & Responsibilities


  • Exhibit effective, innovative, and influential leadership across functions
  • Establish innovative vision and strategies for achieving successful and compliant communications for commercially available products and products in development
  • Strategically assess risks and benefits for promotional and non-promotional communications and establish risk parameters for communications activities by influencing cross-functional teams to develop a common vision of benefits and risks.
  • Provide leadership for effective decision-making, planning, and project management for re-inventing the approach to ALP training
  • Clearly and efficiently analyze issues and communicate options in the face of ambiguity.
  • Effectively build, maintain and motivate a functional regulatory team, including hiring, developing, and coaching a diverse and well-qualified staff.
  • Take ownership for the consequences of difficult decisions.
  • Responsible and accountable for effective project planning and management for multiple products and projects.
  • Effectively manage functional budget.
  • Possess supervisory experience
  • Prioritize development of direct reports
  • Contribute to organizational effectiveness and initiatives
  • Maintains optimism and energy in the face of change and adversity
  • Effectively serve as a role model within regulatory and cross-functionally
  • Willingness to collaborate and problem solve
  • Ability to impact industry and agency organizations
  • Ability to step in for Senior Director as needed


    *LI-RD1

  • Job Requirements:

    Qualifications
  • Minimum 10+ years pharmaceutical/Biotechnology industry experience, 6 years regulatory experience
  • Demonstrate excellent communication skills
  • Demonstrate effective cross-cultural awareness and capabilities
  • Sensitivity for a multicultural/multinational environment
  • Education
  • BA/BS/University Degree required, Life/Health Sciences preferred. Graduate Degree 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

    Director, Commercial Regulatory Affairs

    col-narrow-left   

    Job ID:

    23121

    Location:

    Cambridge, MA 

    Job function:

    Business Development, Legal Services
    col-narrow-right   

    Posted:

    03.11.2016

    Employment Type:

    Full time

    Industry:

    Healthcare / Pharma
    col-wide   

    Title:

    Director, Commercial Regulatory Affairs

    Job Description:

    Position Summary


    Responsible for strategic development and risk assessment of activities in support of external commercial communications. This individual interprets and integrates overall business objectives into departmental and team goals. The Director acts as an integral member of cross-functional teams that establish strategy and vision for promotional materials including patient materials, sales training materials, press materials, and other external communications. Within cross functional teams, this person establishes regulatory strategy for developing draft labeling for regulatory authority review and approval and, after approval, for maintaining labeling documents. This individual represents regulatory affairs within Biogen and externally. This individual has the ability to influence professional organizations and Biogen colleagues at all levels. The Director, ALP should demonstrate strong communication skills, effective cross-functional and cross-cultural skills, with a proficiency strategic business thinking.


    Duties & Responsibilities


  • Exhibit effective, innovative, and influential leadership across functions
  • Establish innovative vision and strategies for achieving successful and compliant communications for commercially available products and products in development
  • Strategically assess risks and benefits for promotional and non-promotional communications and establish risk parameters for communications activities by influencing cross-functional teams to develop a common vision of benefits and risks.
  • Provide leadership for effective decision-making, planning, and project management for re-inventing the approach to ALP training
  • Clearly and efficiently analyze issues and communicate options in the face of ambiguity.
  • Effectively build, maintain and motivate a functional regulatory team, including hiring, developing, and coaching a diverse and well-qualified staff.
  • Take ownership for the consequences of difficult decisions.
  • Responsible and accountable for effective project planning and management for multiple products and projects.
  • Effectively manage functional budget.
  • Possess supervisory experience
  • Prioritize development of direct reports
  • Contribute to organizational effectiveness and initiatives
  • Maintains optimism and energy in the face of change and adversity
  • Effectively serve as a role model within regulatory and cross-functionally
  • Willingness to collaborate and problem solve
  • Ability to impact industry and agency organizations
  • Ability to step in for Senior Director as needed


    *LI-RD1

  • Job Requirements:

    Qualifications
  • Minimum 10+ years pharmaceutical/Biotechnology industry experience, 6 years regulatory experience
  • Demonstrate excellent communication skills
  • Demonstrate effective cross-cultural awareness and capabilities
  • Sensitivity for a multicultural/multinational environment
  • Education
  • BA/BS/University Degree required, Life/Health Sciences preferred. Graduate Degree 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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