Associate Director/Director, Medical Information and Review
What’s in it for you?
The Associate Director or Director, Medical Information and Review, reporting to the Head of Medical Communication & Training, will be responsible for building and leading the Medical Information and Review team. This individual will provide oversight for the provision of scientific and medical information to address unsolicited inquiries from healthcare professionals and other stakeholders. The successful candidate will also be responsible for building and leading the medical review capability to ensure medical accuracy and scientific balance of commercial as well as medical materials, with ample opportunity for growth as we expand our products and pipeline. This highly dynamic role in a rapidly growing company affords the opportunity to bring new ideas and past experiences to grow and shape the department into a high functioning team.
What will you be doing?
- Develop Medical Information strategy and plan, in alignment with global medical strategy
- Develop, maintain, and provide high-quality medical and scientific information, including standard response letters (SRLs), customized responses, and medical frequently asked questions (FAQs) to both internal and external stakeholders.
- Provide oversight for all activities related to the provision and delivery of accurate, scientifically balanced, and timely responses to unsolicited inquiries from healthcare professionals and other stakeholders, coordinating with the global, local/regional Medical Affairs teams to ensure medical information responses address stakeholder needs.
- Represent the medical function in review committees of medical and commercial materials to ensure medical and scientific accuracy, balanced and in proper context, with appropriate references.
- Collaborate with Medical Directors to ensure that materials are aligned to global medical strategy
- Track and report on a regular basis key measures of interest to monitor medical information services and ensure stakeholder needs are met.
- Partner with pharmacovigilance and local /regional medical team to coordinate timely report and triage of adverse events and product complaints
- Lead and staff Medical Information booth at medical meetings
- Build and maintain a robust understanding of Acceleron’s product and pipeline as well as therapeutic areas
- Liaise with medical communications team to develop and maintain timely and relevant product expertise
- Develop and maintain currency of all relevant policy and procedural documents and ensure all employees are appropriately trained
- Manage the Medical Information vendor to ensure quality and compliance with all applicable policies and regulations.
What are we looking for?
The successful candidate will possess the following capabilities and characteristics:
- PharmD, PhD, or other advanced training in life sciences
- 3+ years of experience in the biopharmaceutical industry; previous experience in Medical Information and/or Medical Review strongly desired
- Strong operational capabilities, with an eye for detail and pragmatic, solution-oriented mentality
- Able to search the published medical literature, evaluate published scientific information, and create and communicate balanced accurate and informative responses
- Excellent written and verbal communication skills
- Clinical and /or biopharmaceutical experience in the pulmonary hypertension area highly desired
- Capable of managing shifting priorities in a rapidly changing environment
- Able to thrive as part of a team and when working independently
- Working knowledge of relevant legal, regulatory, and compliance regulations and guidelines
- Ability to travel up to 10%
How will you grow with us?
This role provides an exciting opportunity to be a key player in furthering the company’s goal of becoming a leader in the pulmonary space. As a rapidly growing company with multiple assets in development and key regulatory milestones on the horizon, you have an opportunity to leverage your expertise and help shape the growing Medical Affairs team. With one approved product, and an exciting pipeline, Acceleron is in a phase of dynamic growth with opportunities to make a positive impact on patients’ lives.
*In compliance with federal law, all persons hired will be required to verify identity and eligibility to work in the United States and complete the required employment eligibility verification document form upon hire.
*Recruiters - please do not send unsolicited resumes to this posting.
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Acceleron is a biopharmaceutical company dedicated to the discovery, development, and commercialization of therapeutics to treat serious and rare diseases. Acceleron’s leadership in the understanding of TGF-beta superfamily biology and protein engineering generates innovative compounds that engage the body's ability to regulate cellular growth and repair. Acceleron focuses its research, development, and commercialization efforts in pulmonary and hematologic diseases. In pulmonary, Acceleron is developing sotatercept for the treatment of pulmonary arterial hypertension (PAH), having reported positive topline results of the PULSAR Phase 2 trial. The Company is currently planning multiple Phase 3 trials with the potential to support its long-term vision of establishing sotatercept as a backbone therapy for patients with PAH at all stages of the disease. Acceleron is also investigating the potential of its early-stage pulmonary candidate, ACE-1334, which it plans to advance into a Phase 1b/2 trial in systemic sclerosis-associated interstitial lung disease (SSc-ILD) next year. In hematology, REBLOZYL® (luspatercept-aamt) is the first and only erythroid maturation agent approved in the United States, Europe, and Canada for the treatment of anemia in certain blood disorders. REBLOZYL is part of a global collaboration partnership with Bristol Myers Squibb. The Companies co-promote REBLOZYL in the United States and are also developing luspatercept for the treatment of anemia in patient populations of myelodysplastic syndromes, beta-thalassemia, and myelofibrosis. For more information, please visit www.acceleronpharma.com. Follow Acceleron on Social Media: @AcceleronPharma and LinkedIn.