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Job type: Permanent

Discipline: Laboratory Technician

Location: United States

Proclinical is currently recruiting for a Scientific Material Review Coordinator with a biotechnology company located in Weston, MA.

Job Responsibilities:

Coordinate the development and scientific material review process in the US to ensure the high volume of content is medically appropriate, accurate and consistent with all applicable regulations, laws and SOPs.
Work closely with US marketing, regulatory, medical, legal, GCO, Patient Advocacy and other cross functional stakeholders to drive an efficient and compliant review and approval of all non-promotional materials.
Keep updated on the changes in US regulations or industry code impacting material review process.
Analyze the process execution, provide regular updates to the DSMR team and suggesting improvements to drive efficiency.
Ensure that relevant work instructions, training material and guidelines are up to date and will support corporate compliance and the Standards & Governance office to conduct monitoring of the material review process.
Test changes to the approval system
Provide coordinator support to Congress Materials Project Manager as needed.
Provide operational/workflow management and support for US Materials to the US Medical function, GCO, Patient Advocacy and for global teams hosting events (ie. Ad Boards) in the US, in the technology platforms
Manage the lifecycle of materials
Ensure timely completion of materials through the workflow
Confirm all required stakeholders are engaged and informed in the review process
Validate adherence to company policy and ensuring consistency
Quality control of materials submitted for US DSMR
Liaise with content development and DSMR support vendors
Provide back-up support to other TAs in US DSMR and to Global DSMR and Congress Materials project management
Investigate process bottlenecks
Identify improvements to DSMR-related processes, documents and our technology platform, VAULT InSC2ite for US DSMR

Skills and Requirements:

BS/BA or High School Diploma
A minimum of 2 years of experience in handling material review process for a multinational pharmaceutical company
Previous experience in Pharma industry is an advantage but not required
Experience of using electronic tools such as Zinc MAPS or Veeva Vault for the material review process is preferred
Strong computer aptitude and ability to learn systems quickly
Strong capability in organizing and juggling multiple projects and priorities so that deadlines are met while retaining consistently high-quality outcome
Strong attention to detail
Experience in building solid relationships based on trust and strong ethics
Customer focused
Strong oral, written and presentation skills with ability to explain complex concepts clearly
Anticipate and adapt to change while maintaining accountability
Very good team player. Ability to develop strong network across company
Project Management experience and ability to work in cross-functional teams
Prior work within a Medical or Commercial organization in Pharma is preferred

If you are having difficulty in applying or if you have any questions, please contact Zachary Hines at 215-531-6914.

ProClinical is a specialist employment agency and recruitment business, providing job opportunities within major pharmaceutical, biopharmaceutical, biotechnology and medical device companies.

Proclinical Staffing is an equal opportunity employer.

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