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Randstad US senior manager reg cmc lead in cambridge, Massachusetts

senior manager reg cmc lead.

  • cambridge , massachusetts

  • posted august 25, 2022

job details

summary

  • $71.86 - $84.55 per hour

  • contract

  • bachelor degree

  • category life, physical, and social science occupations

  • reference42954

job details

job summary:

As the world's largest staffing and recruitment agency in the world, we can commit to find you the perfect role that gives you the opportunity to learn and grow in the life sciences arena. Utilizing a recruiter for your job search gives you access to a large network of top employers as well as detailed information about hundreds of positions. With a hefty goal of discovering medical breakthroughs to treat devastating neurological ailments, our partner is focused on furthering research and finding ways to improve our healthcare system. You can feel secure in the fact that you will be paving the way to life changing practices when you work for this well-known team!

This role requires employees to be fully vaccinated against COVID-19 as a condition of employment, subject to a valid medical or religious accommodation.

location: Cambridge, Massachusetts

job type: Contract

salary: $71.86 - 84.55 per hour

work hours: 9 to 5

education: Bachelors

responsibilities:

  • Need a temporary resource for (oligonucleotide) small molecule development programs with US/EU submission expected.

  • Specifically, regulatory CMC professional with small molecule development experience.

  • Experienced in preparing submissions IND/IMPDs for P 1, 2 and 3 programs and late-stage program support for NDA or MAA) and oversight of development team working on the Asset team.

qualifications:

REQUIRED SKILLS:

  • Regulatory Affairs, Small molecule CMC experience - specifically global CMC focus on IND, IMPD and CTA submissions and Agency response to questions.

  • Ideally experience with coordinating or contributing to global filing CTD content within M3.

  • Regulatory experience with global regulatory strategy, operations and planning for the CMC aspects of assigned projects/products.

ADDITIONAL REQUIREMENTS:

  • Experienced in technical/regulatory writing.

  • Successful authoring and contribution to delivering CMC submission documents of development.

  • Good communication skills and experience working cross-functionally and globally. Quick learner and able to navigate electronic systems to find information and to the given program.

  • Ability to work, with responsibility, both independently and within project teams or committees to attain group goals and key project milestones.

skills: CMC, IND, CTD Structure

Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.

At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.

Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).

For certain assignments, Covid-19 vaccination and/or testing may be required by Randstad's client or applicable federal mandate, subject to approved medical or religious accommodations. Carefully review the job posting for details on vaccine/testing requirements or ask your Randstad representative for more information.

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