Job Title: Writer
Location: Cambridge, MA
Duration: 3+months (Possibilities of extension)
Job Roles & Responsibilities
·This Project Manager position supports the Content Development (SRL Writing) work streams.
·This role provides operational and project management support to ensure that Standard Response Letters (SRLs) are of high-quality and are delivered on time.
·The position is also responsible for drafting SRLs and providing quality reviews as needed, and maintenance of these information assets.
·This position works closely with the medical writing vendor and internal stakeholders within or outside of medical affairs.
Responsibilities include serving as the point contact interacting with the medical writing vendor, coordinating pertinent work streams, and overseeing outsourced SRLs/FAQs development processes; drafting and/or oversight of the development of Medical Information SRLs for assigned products; coordination of Content Development work-streams within or outside of Global Medical; providing internal Medical Information quality reviews of SRLs as needed; maintenance of SRLs within the database.
1) Vendor Management – manage/oversee SRLs/FAQs development processes. Includes researching scientific literature and internal research documents and data feeding the vendor; tracking SRLs/FAQs development status in Veeva; documenting and reporting KPI metrics; facilitating review and approval processes.
2) Quality Reviewer – serve as MI quality reviewer for SRLs/FAQs as needed and provides guidance on MI formatting, as well as scientific accuracy.
3) Drafting of SRLs (including the PML safety update) – create/update SRLs as needed, formatting new content according to approved templates, coding key metadata for SRL assets into central database, facilitation of internal review and approval process.
4) Maintenance of Information Assets – manage SRLs in Veeva, central database, and shared site with the vendor.
5) SRL Project Planning – provide assistance in annual strategic SRL planning. Own and implement per annual SRL plans.
REQUIREMENTS:
Advanced medical/scientific training, i.e., MD, PhD, PharmD, Master’s level degree, preferably in the life sciences, Bachelor in Nursing, or similar qualifications.
• 3+ years Medical Information or relevant experience.
• Medical writing and editing capabilities.
• Project management experience preferred.
• Computer skills and experience in Microsoft Office Suite software, Endnote software, Veeva/Vault, and web based inquiry database.
• Organizational skills.
• Ability to work independently.
• Presentation skills.
• Neurology experience preferred.
• Pharmaceutical industry experience preferred.
• Knowledge of regulatory requirements preferred.