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|Biogen Idec (NASDAQ: BIIB) is a biotechnology leader that discovers, develops and delivers medicines to improve the lives of patients. As a company, Biogen Idec recognizes that cutting-edge science and medicines can address unmet patient needs to change the course of devastating diseases. |
Founded in 1978, Biogen Idec is the worldâ€™s oldest independent biotechnology company. Patients worldwide benefit every day from our industry-leading multiple sclerosis (MS) products. We have one of the strongest late-stage pipelines in the industry. In the coming years, weâ€™re working hard to bring new therapies to market for patients with MS, amyotrophic lateral sclerosis (ALS, or Lou Gehrigâ€™s Disease), hemophilia, and others.
With more than 5,000 employees, Biogen Idec is a truly global organization â€“ generating revenue of more than $5 billion worldwide in 2011. In addition to our headquarters in Weston, MA, and our research operations in Cambridge, MA, we have world-class manufacturing facilities in North Carolina and Hillerod, Denmark and offices in Canada, Australia, Japan and throughout Europe. We also have a direct commercial presence in 29 markets, including the US, EU, Brazil, China and India, and a network of distribution partners in more than 70 additional countries.
|Associate General Counsel, R&D, Legal|
|Position: Associate General Counsel, R&D, Legal (Director Level)|
Summary: The successful candidate for this position will be someone with significant, specialized experience with global regulatory requirements in the bio/pharma industry and a strong team orientation. This Attorney will work with other Attorneys in Biogen Idecâ€™s Legal Department on matters relating to regulatory requirements for investigational and approved products, regulatory submissions, clinical trials, drug safety management, labeling and label modification, as well as R&D and clinical compliance regulations. The successful candidate will have direct client responsibility in support of a broad range of company R&D related activity and may also serve as a dedicated lawyer for one or more of Biogen Idecâ€™s late stage development programs. Position reports directly to the VP, Chief R&D Counsel.
Specific responsibilities may include:
â€¢ Review and advise on key global regulatory filings (sBLA/BLA) and briefing documents
â€¢ Work with cross functional pre-launch team to develop product target profile and target labeling; anticipate and advise on label and approval challenges.
â€¢ Provide regulatory environment (US and ROW) updates on key activities at FDA, EMA and other global agencies that may affect our product approvals and marketed products.
â€¢ Advise Drug Safety on recent developments in risk management
â€¢ Proactively identify and manage risk profile of products in development to be best prepared to prevent and address clinical trial and post marketing products liability claims.
â€¢ Work with Drug Safety to ensure compliance with safety reporting, risk management and other post marketing safety commitments.
|Legal & Compliance|
â€¢ 10+ years experience with global regulatory requirements in the bio/pharma industry required.
â€¢ Experience with regulatory submissions, requirements and drug safety management is required.
â€¢ Experience with government affairs, FDA and EMA regulations are required.
â€¢ Must have excellent interpersonal, decision making and communication skills.