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Regulatory CMC Project Management and Outsourcing lead
Biogen | Cambridge, Massachusetts
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Job Description

External Posting TitleRegulatory CMC Project Management and Outsourcing lead
Job DescriptionThe Regulatory CMC Project Management and Outsourcing lead is accountable at a global level for directing all Regulatory CMC project management activities (planning, tracking, reporting and resourcing) to ensure successful implementation and delivery of innovative regulatory CMC Projects, within scope, deadlines and budget while working in close collaboration with Global Regulatory leads and teams, Asset Development and Portfolio Management and Regulatory Affairs teams. The incumbent will apply prior knowledge of Regulatory CMC procedures and experience of planning and managing efficient processes to ensure improvements to existing ways of working.

Principal Responsibilities:

•Outsourcing: Accountable for planning, tracking and budgeting of outsourcing activities as well as building and maintaining strong and effective business relationships with both internal as well as external stake holders, setting exemplary behaviors of communication and relationship management.
-Prepares and delivers effective reports and presentations for internal audiences
-Develop partnerships with Key Outsourcing contractors, ensuring metrics for performance are agreed and tracked for Reg CMC and technical writing activities and negotiations completed to ensure they are successfully met and within budget, as well as identifying areas for future improvement

•Establish and execute process for scoping out needs, identifying, selecting, and recruiting most effective outsourcing partners (flexible resourcing ) to ensure differing needs of Reg CMC are met globally

•Responsibility for the successful development and implementation of creative Reg. CMC regulatory planning and tracking tools, aligned with those of ADPM and Regulatory Affairs, to ensure new registration submissions are successfully achieved and post-approval submissions completed, to ensure timely compliance for all Assets and markets

•Develop a resource tool, aligned with planning, to provide effective resource information across all Reg CMC activities, to provide guidance to Senior Management on actual and trends of resource usage and allow forecasting and support of Reg CMC efficient resource needs

•Work with GRLs and Reg CMC teams to ensure proactively identify (identify gaps)and assess risks associated with the planned activities, across program and regions and suggestions made to mitigate risks

•Lead all planning, tracking, risk assessment and resource information reporting, presented in simple, value adding reports, with clear trend recommendations made, for use in forecasting for projects and resources, for use by GRLs, senior management and stakeholders

LocationCambridge, MA, US
Job CategoryRegulatory
Requisition Number31929BR
•Minimum 8-10 years pharmaceutical/biotechnology industry experience (including 3 years Regulatory Affairs CMC procedural experience),

•Proven ability to successfully project manage (planning, tracking and outsourcing management experience an advantage

•Demonstrated, strong organizational skills including the ability to prioritize personal workload and able to think innovatively and use initiative to make recommendations for further improvements to systems and processes

•Strong communication and other interpersonal and cultural skills, with the ability to deal effectively with a variety of personnel including technical, drug safety, scientific, and manufacturing staff and build good relationship management with Outsourcing partners
•Minimum BA/BS/University degree required, Life/Health Sciences preferred

•Project Management qualification (e.g. PMP, APM , PRINCE2 etc.) preferred
About BiogenCorporate Overview

Through cutting-edge science and medicine, Biogen discovers, develops and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. Biogen is a pioneer in biotechnology and today the Company has the leading portfolio of medicines to treat multiple sclerosis (MS), has introduced the first and only approved treatment for spinal muscular atrophy, and is at the forefront of neurology research for conditions including Alzheimer's disease, Parkinson's disease and amyotrophic lateral sclerosis (ALS). Biogen also manufactures and commercializes biosimilars of advanced biologics. Our global organization of nearly 7,000 employees is committed to a single mission: making a meaningful difference in the lives of patients with few or no treatment options.

One of the pioneers in biotechnology, Biogen was founded in 1978 and today serves patients in nearly 90 countries. Our global headquarters and R&D operations are located in Cambridge, Massachusetts, with an international headquarters in Zug, Switzerland, world-class manufacturing facilities in Research Triangle Park, North Carolina, USA and Hillerod, Denmark, and affiliate locations around the world.

Our Science

We aspire to have the greatest impact on patients and science of any biotechnology company in the history of our industry. To us, that means creating novel medicines that benefit individuals and society, and bringing new scientific understanding to diseases for which there are no adequate treatments.

For nearly two decades Biogen has led in the research and development of new therapies to treat MS, including the most prescribed oral treatment in the world. Now our research is driving revolutionary new MS treatments with the goal of reversing or even repairing damage caused by the disease. We are now applying our neurological expertise to solve some of most challenging and complex diseases of the brain, including Alzheimer's disease, Parkinson's disease, and ALS. As we uncover new insights into human biology, Biogen is employing cutting-edge technologies to discover potential treatments for rare and genetic disorders.

Biogen is revolutionizing biologics manufacturing, developing the industry's most advanced plants and processes. This expertise is used to produce both original innovative therapies and biosimilars that expand patient access to lower-cost medicines.

Our Corporate Citizenship

The same intellectual discipline and passion that drives our science is reflected in our corporate citizenship, environmental sustainability, and commitment to diversity and inclusion. As a company, we are focused on improving science education and limiting the impact of our company on the environment. In 2015, we became a carbon neutral company and ranked first place on Newsweek's 2015 Green Rankings, and we are an industry leader on the Dow Jones Sustainability World Index. Biogen was named to Science's list of Top Employers of 2015 and in 2017 received a perfect score of 100 for the fourth consecutive year on the Human Rights Campaign (HRC) Corporate Equality Index, which also named Biogen as one of its Best Places to Work.

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 States.

Please be advised that all legitimate correspondence from a Biogen employee will come from "@biogen.com" email accounts.

About Biogen

Biogen Idec Inc. is engaged in the development, manufacturing, and commercialization of therapies. The Company's products address diseases such as multiple sclerosis, lymphoma and rheumatoid arthritis. The Company has four products: AVONEX (interferon beta-1a), RITUXAN (rituximab), TYSABRI (natalizumab) and FUMADERM (dimethylfumarate and monoethylfumarate salts). AVONEX is used in the treatment of relapsing forms of multiple sclerosis (MS). RITUXAN is used in the treatment of relapsed or refractory low-grade or follicular, CD20-positive, and B-cell, non-Hodgkin's lymphomas (B-cell NHLs). TYSABRI is approved for the treatment of relapsing forms of MS. FUMADERM acts as an immunomudulator. It also has product candidates, such as BG-12 (acquired with the purchase of Fumapharm), ANTI-CD80 antibody/(galiximab), ANTI-CD23 antibody/(lumiliximab), Ocrelizumab/(Humanized ANTI-CD20 Antibody) and Lixivaptan.In January 2007, the Company completed the acquisition of Syntonix Pharmaceuticals, Inc. (Source: 10-K)

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