Advanced degree in life sciences (e.g. PharmD, PhD, MD, or equivalent) required., Minimum of 5 years of relevant experience in Medical Information or Medical Communications in the biotech industry., Strong knowledge of regulatory guidelines and compliance requirements., Excellent scientific writing and communication skills..
Key responsabilities:
Develop and implement the Medical Information strategy and inquiry management process.
Oversee operations of the Medical Information Call Center, including training and compliance monitoring.
Lead the creation and approval of Medical Information content such as FAQs and standard response letters.
Monitor inquiry trends to inform scientific communications and partner with cross-functional teams for accuracy.
Report This Job
Help us maintain the quality of our job listings. If you find any issues with this job post, please let us know.
Select the reason you're reporting this job:
Born from social and inspired by culture, we’re champions of storytelling across the platforms and technologies that shape the internet; today and tomorrow.
We work with global brands to connect the dots in a maze of swipe, tap, forgettable.
Scholar Rock is a biopharmaceutical company that discovers, develops, and delivers life-changing therapies for people with serious diseases that have high unmet need. As a global leader in the biology of the transforming growth factor beta (TGFβ) superfamily of cell proteins and named for the visual resemblance of a scholar rock to protein structures, the clinical-stage company is focused on advancing innovative treatments where protein growth factors are fundamental. Over the past decade, the company has created a pipeline with the potential to advance the standard of care for neuromuscular disease, cardiometabolic disorders, cancer, and other conditions where growth factor-targeted drugs can play a transformational role.
Scholar Rock is the only company to show clinical proof of concept for a muscle-targeted treatment in spinal muscular atrophy (SMA). This commitment to unlocking fundamentally different therapeutic approaches is powered by broad application of a proprietary platform, which has developed novel monoclonal antibodies to modulate protein growth factors with extraordinary selectivity. By harnessing cutting-edge science in disease spaces that are historically under-addressed through traditional therapies, Scholar Rock works every day to create new possibilities for patients. Learn more about the company’s approach at ScholarRock.com and follow @ScholarRock and on LinkedIn.
Summary of Position
Reporting to the Head of Scientific Communications and Medical Excellence, the Medical Information and Content Lead will be responsible for developing, managing, and delivering high-quality, accurate, and compliant medical content to support HCPs. You will also lead the global medical information strategy ensuring timely and accurate responses to medical inquiries across our therapeutic areas. This role necessitates a comprehensive understanding of medical information with a strong emphasis on project management, medical writing, and strategic thinking.
Position Responsibilities
Develop and implement the Medical Information strategy, including inquiry management process, standard response letters (SRLs), FAQs, and escalations as needed.
Oversee the day-to-day operations of the Medical Information Call Center (MICC), including vendor and agent performance, training, quality monitoring, and compliance with SOPs and regulatory standards.
Ensure the MICC agents are equipped with up-to-date scientific content and trained to respond accurately and professionally to HCP inquiries.
Review and triage Medical Information Request Forms (MIRFs) submitted by MSLs ensuring accurate, timely, and compliant delivery of medical responses in alignment with internal processes.
Monitor and analyze inquiry trends and insights to inform scientific communications and strategic planning.
Lead the creation and approval of Medical Information content including FAQs, SRLs, and Custom Response documents.
Partner with cross-functional teams to ensure scientific accuracy and compliance with regulations.
Serve as a Subject Matter Expert for medical content and information processes; provide training and guidance to internal stakeholders on Medical Information Systems and processes.
At times, serve as a member of the Medical Review Committee and Promotional Review Committee to ensure scientific accuracy of Medical and Promotional assets.
Provide support to ongoing global medical congress initiatives.
Lead development of the monthly Medical Information dashboard.
Other duties as periodically assigned.
Candidate Requirements
Advanced degree in life sciences (e.g. PharmD, PhD, MD, or equivalent required).
Minimum of 5 years of relevant experience in Medical Information, Medical Communications, or related function in the biotech industry.
Experience in content creation, review, and approval processes; strong knowledge of regulatory guidelines and compliance requirements.
Strong scientific writing and written communication skills.
Ability to interpret clinical data and present it clearly and accurately.
Ability to thrive in a fast-paced environment with strong ability to simultaneously handle multiple activities, prioritizing and pivoting as necessary.
A minimum of 20% travel is required.
Required profile
Experience
Spoken language(s):
English
Check out the description to know which languages are mandatory.