Associate Director, Compliance Operations
Posted on: 9 Jan 2021
Cambridge, MA
Job Description
Job Description
This role directs the global strategy for the Written Standards of the Company, including the ongoing design of the policy architecture and management of Biogens Code of Business Conduct, the Corporate global policies, Standard Operating Procedures (SOPs) and other guidance. Additionally this role will be responsible for the development and ownership of the Global Compliance Training and Communications Plan.
* Owns the continual design and maintenance of the Global Corporate Compliance Policy Architecture. Including oversight of policy and guidance stakeholder review, approval and management
* Responsible for the upkeep of all Corporate Compliance owned policies and guidance: COBC, COI, ABAC, TPI and ESE Guidance
* Owns the development and adhere to the Corporate Compliance Training and Communications Plan Globally
Qualifications
* 10+ years of Biopharma industry providing advice or working in legal or compliance related areas with a focus on writing policies and interacting with Internal Audit.
* Previous experience in gathering information, requirements, assessing gaps and translating complex requirements into understandable corporate policy.
* Experience managing end-to-end Vendor and Healthcare Provider engagements including Due Diligence Checks, Fair Market Value calculations and contracting
* Previous experience in developing an internal company communications process related to Compliance themes.
* Program and Project management experience
* Previous experience presenting results
* Full knowledge of MS suite of products (MS office, word, excel, powerpoint)
* Excellent Communication Skills and ability to influence a breadth of teams
* Bachelor's Degree Required
* JD or other relevant Advanced Degree is Preferred
Additional Information
All your information will be kept confidential according to EEO guidelines.
Biogen
Cambridge, MA
Biogen Inc. discovers, develops, manufactures, and delivers therapies for treating neurological and neurodegenerative diseases worldwide. The company offers TECFIDERA, AVONEX, PLEGRIDY, TYSABRI, and FAMPYRA for the treatment of multiple sclerosis (MS); SPINRAZA for the treatment of spinal muscular atrophy; and FUMADERM for the treatment of plaque psoriasis. It also provides BENEPALI, an etanercept biosimilar referencing ENBREL; FLIXABI, an infliximab biosimilar referencing REMICADE; and IMRALDI, an adalimumab biosimilar referencing HUMIRA. In addition, the company offers RITUXAN for the treatment of non-Hodgkin's lymphoma, chronic lymphocytic leukemia (CLL), rheumatoid arthritis, two forms of ANCA-associated vasculitis, and pemphigus vulgaris; RITUXAN HYCELA for non-Hodgkin's lymphoma and CLL; GAZYVA to treat CLL and follicular lymphoma; and OCREVUS for the treatment of primary progressive MS and relapsing MS, and other anti-CD20 therapies.
Further, it is involved in developing BIIB098, Opicinumab, and BIIB061 for MS and neuroimmunology; Aducanumab, Elenbecestat, BAN2401, BIIB092, BIIB076, and BIIB080 to treat Alzheimer's disease and dementia; BIIB092 and BIIB054 for treating Parkinson's disease and movement disorders; BIIB067, BIIB078, and BIIB110 to treat neuromuscular disorders; BIIB093, TMS-007, and Natalizumab to treat acute neurology; BIIB104 for treating neurocognitive disorders; BIIB074 and BIIB095 for pain; and Dapirolzumab pegol, BG00011, and BIIB059 for treating other diseases, which are under various stages of development.
The company offers products through its sales force and marketing groups. Biogen Inc. has collaboration agreements with Genentech, Inc., Eisai Co., Ltd., Alkermes Pharma Ireland Limited, Bristol-Myers Squibb Company, Acorda Therapeutics, Inc., AbbVie Inc., C4 Therapeutics, University of Pennsylvania, Applied Genetic Technologies Corporation, and others. The company was founded in 1978 and is headquartered in Cambridge, Massachusetts.
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IndustryBiotechnology
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No. of Employees7,800
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Website
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Jobs Posted445
