Manager, Standards & Governance Otro

  • Empresa
  • Buenos Aires
  • 23-09-2016
  • Otros

External Posting TitleManager, Standards & Governance

The standards and governance manager is responsible for
providing support to the affiliate on matters related to SOP development,
review, approval, implementation, communication, control, process enhancement
and Compliance related matters, in accordance with the guidelines from the
Latam Compliance Director.
Primary Responsibilities:
* SOP/Policy/Work Instruction management: write/coordinate, update, upload, control, and document all affiliate SOPs
* Coordination of training monitoring including all aspect of BIU and ISOtrain
* To conduct training of internal staff and external stakeholders on relevant QA and certain compliance topics, ( local industry codes, key policies and procedures)
* Handling, reporting and documentation of promotional material withdrawal. To initiate, execute and monitor any possible recalls.
* Assure the appropriate control and filling process of Biogen corporate documents.
* Work with DSMs to monitor free text in Biogen systems and tools
* Support the Latam Compliance Director on an as-needed basis in performing monitoring of identified high risk activities (, payments to HCPs, grants, sponsorships, marketing activities), including monitoring of local regulatory and update of systems and tools to meet these requirements
* Assist the Latam Compliance Director on an as-needed basis to help ensure key compliance records and tools are well-organized and stored, that policies and procedures are stored adequately and easily accessible to all employees
* Assist the global regulatory team on an as-needed basis
* Responsible for all aspects of contract management. Support to Legal Director in dealing with Contracts Lifecycle and Development.
* Responsible for the Powers-of -attorneys (granting and revocation), legalization and certification before Public Notaries, responsible for Corporate Books and Minutes of Meetings. Represent the company before CAEME (Argentinean Chamber of Medical Specialties) and responsible for legal documentation before SEDRONAR and ANMAT.
LocationBuenos Aires, Argentina
Job CategoryGlobal Commercial Strategy
Requisition Number28216BR
* A minimum of 1-2 years of experience in the similar role, ideally in pharma or biotechnology industries
* Knowledge of local Latam regulatory and market requirements Data driven and minute attention to detail
* Experience with writing and developing policies and guidelines
* Excellent and professional communication, presentation and stakeholder engagement skills
* Ethical and integrity-driven approach and objectivity.
* Compliance, Legal or Regulatory background is a plus.
* Fluent Portuguese and Spanish languages.
* College degree or any other relevant education
About BiogenBiogen (NASDAQ: BIIB) is a biotechnology leader that discovers,
develops and delivers innovative therapies for the treatment of
neurodegenerative and rare 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 independent 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 Alzheimer’s Disease,
amyotrophic lateral sclerosis (ALS), Parkinson’s disease, spinal muscular
atrophy and neuropathic pain amongst others.
With more than 7,000 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
All qualified applicants will receive consideration for employment without
regard to sex, gender identity or expression, sexual orientation, marital
status, race, color, national origin, ancestry, ethnicity, religion, age,
veteran status, disability, genetic information or any other basis protected
by federal, state or local law. Biogen is an E-Verify Employer in the United
Please be advised that all legitimate correspondence from a Biogen employee
will come from “biogen” email accounts.

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