What are the responsibilities and job description for the PROJECT COORDINATOR - REGULATORY AFFAIRS, CMC position at Yoh Services LLC?

Please contact

Renu Goel

857-207-2676

renu.goel@yoh.com

Project Coordinator - Regulatory Affairs, CMC (Life Sciences Industry Experience)

Cambridge, MA : Hybrid

Contract with perm potential at the end of the year (11 month contract)

Pay rate : $50 - $55 (depending on experience)

The successful candidate for this role will have a bachelor's degree with at least 2 years' experience in one or more of the following : Project Coordination / Project Management, IT, biotechnology / pharmaceutical industry
Past experience in a business area that utilizes core project management techniques and tools is required along with linking various project management tools within a company to ensure regulatory CMC timelines reflect accurate data.
Exposure to regulatory filings and familiarity with CTD structure / content a plus.

Experience & Responsibilities :

Providing consistent, high-level project management support to regulatory affairs and CMC teams

Ensure global regulatory submissions stay on track in alignment with program objectives

Supporting regulatory filings including early phase, late stage, commercial and life cycle management projects

Collaborate with regulatory CMC program leads, regulatory operations, global regulatory teams, IT, project management and operations

Basic project management skills : ability to think creatively to problem solve, identify bottlenecks, understand critical path, and escalate issues appropriately in a timely fashion

Ability to prioritize multiple projects

Proficient in project management related technical systems (i.e. Smartsheets, MS Project, Visio, and Excel, SharePoint)

Experience in Think-Cell, Milestones Professional, OnePager a plus

Demonstrated ability to learn IT systems quickly and be able to navigate meta-data, build reports, data mine

Excellent organizational and meeting management / facilitation skills

Good communication skills, including written and verbal communications

Strong interpersonal skills and ability to work in a team environment

Contribute to the development of project plans and timeline with a CMC focus, including defining key tasks, resources, critical path items, gating activities.

Maintain and update existing project plans and timelines

Track deliverables

Develop and disseminate project communication tools (agendas, minutes, action items)

Participate in and coordinate RA CMC infrastructure and capability building projects.

Assist in building cross-links between various project management tools within Alnylam to ensure RA CMC timelines reflect accurate, up-to-date data

Provide administrative support for RA CMC team including reserving conference rooms, planning meetings / workshops, food, etc.

Maintain project dashboard

Estimated Min Rate : $45.50

Estimated Max Rate : $55.00

Note : Any pay ranges displayed are estimations. Actual pay is determined by an applicant's experience, technical expertise, and other qualifications as listed in the job description. All qualified applicants are welcome to apply.

Yoh, a Day & Zimmermann company, is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran.

Visit https : / / www.yoh.com / applicants-with-disabilities to contact us if you are an individual with a disability and require accommodation in the application process.

For California applicants, qualified applicants with arrest or conviction records will be considered for employment in accordance with the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act. All of the material job duties described in this posting are job duties for which a criminal history may have a direct, adverse, and negative relationship potentially resulting in the withdrawal of a conditional offer of employment.

Salary : $50 - $55

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What are the responsibilities and job description for the PROJECT COORDINATOR - REGULATORY AFFAIRS, CMC position at Yoh Services LLC?

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Job openings at Yoh Services LLC

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