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    <job>
        <title><![CDATA[Head of Regulatory Affairs]]></title>
        <description><![CDATA[Head of Regulatory Affairs
Tracking Code
2008091
Job Description
Reporting to the Chief Medical Officer, the Head, Regulatory Affairs will establish and implement a long-term, world-wide regulatory vision for Acceleron, assuring the regulatory viability of drug candidates in development, while forecasting the regulatory environment to identify changes that may impact the Company.
Job Responsibilities:
An integral part of the organization, he or she will provide overall leadership and initiative for Acceleron's regulatory strategies by maintaining an ongoing dialogue with the FDA, and as necessary the EMEA, overseeing regulatory documentation, filings and registration process, and providing regulatory strategic input into development teams.
Directing all policy development, planning and implementation, the Head will represent the Company to the FDA and other regulatory bodies on matters involving development, manufacture, testing and distribution of investigational products.
Dedicated to and responsible for building the regulatory function at Acceleron, the Head will establish the function's overall priorities, objectives, standards and measures. Further, he or she will be responsible for regulatory affairs operational capabilities, including filing of INDs, annual reports, adverse event filings, maintenance of documentation (archiving), and other activities required to conduct clinical trials. Additionally, the Head will direct the organization and preparation of product registration dossiers for international registration activities.
Required Skills
The Head, Regulatory Affairs will possess a PhD, MD, PharmD or equivalent experience, and at least 10 years professional experience in technical and regulatory disciplines, including the management of a regulatory function. A first-rate manager, he or she must have established credibility and an expert reputation within the profession, the FDA and other regulatory agencies. Further, the Head must have experience with multiple prior NDA/BLA filings and approvals. The Head must also possess experience in directly negotiating the text of product labeling based on data from preclinical trials and obtaining optimal/superior results for the Company. Additionally, he or she must have a solid basis in scientific approach and an ability to deal with in-depth information from a variety of disciplines, fostering a high degree of scientific credibility with regulatory agencies.
Job Location
Cambridge, MA, US.
Position Type
Full-Time/Regular]]></description>
        <link><![CDATA[http://jcnlx.com/54f2c5dd9b3c46f1bad62cb1ac85e123105]]></link>
        <imagelink>http://images.jobcentral.com/companylogos/acceleron.gif</imagelink>
        <guid isPermaLink="false"><![CDATA[acceleron-281437]]></guid>
        <industries>
            <industry><![CDATA[Hospital / Healthcare]]></industry>
        </industries>
        <expiration_date>2009-11-26</expiration_date>
        <employer><![CDATA[Acceleron Pharma]]></employer>
        <location><![CDATA[Cambridge, MA, 02238, USA]]></location>
    </job>
    <job>
        <title><![CDATA[Research Associate, Process Development]]></title>
        <description><![CDATA[Research Associate, Process Development
Tracking Code
2009061
Job Description
We have an immediate opening for a Research Associate to join the Protein Biochemistry Process Development group.
&#160;
Required Skills
This person will be involved in the purification and characterization of our target proteins. Qualified individuals will be able to develop, optimize, and scale up robust purification schemes.&#160; This position will involve providing technical solutions to compliment the technology transfer of purification processes to suitable mid to large scale clinical manufacturing platforms.&#160; He/She should be highly motivated, hands-on, and unafraid to approach new challenges while being able to work independently as well as in a team environment.
Required Experience
A B.S. /M.S. in Biochemistry or a related discipline with 2-5 years experience working in a process development role. This individual should have extensive experience with protein purification using chromatography resins such as affinity, ion exchange, and size exclusion. &#160;&#160;Knowledge of current column chromatography and non-chromatography related downstream process steps, as well as experience in a GLP/cGMP environment working with FPLC/HPLC is desirable. Experience with analytical techniques such as SDS-page gels and Western Blotting is preferred
Job Location
Cambridge, MA, US.
Position Type
Full-Time/Regular]]></description>
        <link><![CDATA[http://jcnlx.com/7f5d45cb3e684e20841d2760fb2f8163105]]></link>
        <imagelink>http://images.jobcentral.com/companylogos/acceleron.gif</imagelink>
        <guid isPermaLink="false"><![CDATA[acceleron-290617]]></guid>
        <industries>
            <industry><![CDATA[Hospital / Healthcare]]></industry>
        </industries>
        <expiration_date>2009-11-26</expiration_date>
        <employer><![CDATA[Acceleron Pharma]]></employer>
        <location><![CDATA[Cambridge, MA, 02238, USA]]></location>
    </job>
</jobs>