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Program Manager - Scientific - Senior

Kelly Services


Location:
Cambridge, MA
Date:
04/19/2018
2018-04-192018-05-19
Job Code:
US33MXMP_BH1435338
Categories:
  • Legal
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Job Details

Job Title Program Manager - Scientific - Senior

Jobid US33MXMP_BH1435338

Location: Cambridge, MA, 02238, USA

Description **_Program Manager - Scientific – Senior_**



+ For assigned projects, is responsible for working collaboratively with the Global Regulatory Lead (GRL) and cross functional project teams to provide project management support to ensure global regulatory strategies are developed and seamlessly executed upon, enabling successful filings with Health Authorities.
+ Manages and provides supports with the planning and execution of high quality regulatory submissions for assigned products, including both pre-approval and postmarketing submissions. This includes major global regulatory submissions (NDAs, BLAs, MAAs, INDs, and supplementals) and other US submissions including amendments/supplements, annual reports, study protocols, study reports, investigator brochures, safety reports, label updates etc.,consistent with US regulatory requirements. Responsible for drafting and preparation of forms and cover letters required for US Submissions.

**_Responsibilities_**


**_% of Time_**


**_Job Function and Description_**


40



+ Provide project management support for product-specific global regulatory team meetings (GRTs) and cross-functional major submission team meetings to oversee, plan and deliver GRT goals and regulatory submissions.
+ For assigned programs, prepare meeting agendas, meeting minutes,and together with the team prepare effective issue and risk management plans.Develop and actively manage project timelines and integrated submission project plans. Prepare and distribute reports and trackers to communicate updates and project status.
+ For speficied programs, proactively drive project teams, establishing an appropriate level of urgency and keen focus on deliverables.Track Project variances and assist in the identification of root causes. Conduct lessons learned sessions to identify areas for improvement.

50



+ Plan and coordinate the delivery of US submissions, including authoring of certain M1 components (e.g. drafting of forms and cover letters).
+ Coordinate and consult with GRL and other departments on the content, preparation and assembly of regulatory documentation in support of US filings. Perform final editorial checks of regulatory content prior to hand off to submission management.
+ Coordinate and provide operational support for FDA meeting requests, meeting rehearsals, briefing book preparations and assist in the preparation of meeting minutes of FDA meetings.
+ For specified programs, support the GRPMUS Leads with project management and tactical exection of regulatory strategy deliverables for complex programs/projects.

10



+ Responsible for ensuring regulatory compliance for all assigned responsibilites.
+ Act as a conduit of information between assigned cross-functional submission teams and the GRT.
+ Work with submission management on the development of regulatory submissions.


**_Education and Experience Requirements_**



+ BA/B.S in a scientific, healthcare or related field or equivalent experience
+ 4+ years project management experience in RA or Drug Development required. 2+ years experience in Regulatory Affairs required.
+ Knowledge of FDA regulations and guidelines on drug development and the approval process for NDA/BLA and postmarketing supplements

**_Key Skills, Abilities, and Competencies_**



+ Excellent communication skills both written and verbal
+ Excellent interpersonal and negotiation skills
+ Demonstrates strong ability to collaborate, interact and work effectively with other departments as well as external organizations
+ Excellent organizational skills, ability to multitask and with attention to detail; capable of managing multiple projects within assigned timelines
+ Ability to apply scientific principles to assess regulatory issues, request and collect relevant information, analyze data, establish facts and draw valid conclusions
**Why Kelly?**

**For immediate consideration, if you meet the above requirements, please email a current copy of your CV to meghan.porter@kellyservices.com or click 'apply now'.**
**You pursued a career in science to fuel your quest for knowledge and your desire to make the world a better place.**

**Let Kelly fuel your career—connect with us today.**


_*Available for purchase and administered by a designated third-party vendor_

_Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females, Individuals with Disabilities, Protected Veterans, Sexual Orientation, and Gender Identity, and is committed to employing a diverse workforce._

**Why Kelly** **®** **?**

At KellyServices ® , we work with the best. Our clients include 95 of the Fortune100 ™ companies, and more than 70,000 hiring managers rely on Kelly annually to accessthe best talent to drive their business forward. If you only make one career connection today, connectwith Kelly.

**AboutKelly Services** **®**


As a workforce advocate for over 70 years, we are proud to directly employ nearly 500,000 peoplearound the world and have a role in connecting thousands more with work through our global network oftalent suppliers and partners. Revenue in 2017 was $5.4 billion. Visit kellyservices.com and connect with us on Facebook, LinkedIn and Twitter .

Kelly Services is an equal opportunity employer including, but not limited to, Minorities, Females,Individuals with Disabilities, Protected Veterans, Sexual Orientation, Gender Identity and iscommitted to employing a diverse workforce. Equal Employment Opportunityis The Law.



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