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