Associate Director, Publications

Ardelyx•Waltham, MA

15h•Onsite

About The Position

Ardelyx is a commercial-stage biopharmaceutical company focused on redefining treatment approaches for patients with significant unmet medical needs. By combining scientific innovation with a collaborative, purpose-driven culture, we strive to create meaningful impact for patients. Team Ardelyx is united by a shared mission and guided by our core values: Passionate, Fearless, Dedicated, and Inclusive. We foster an inclusive environment where employees are respected, supported, and empowered to make an impact — both within our company and in the lives of patients we serve. Position Summary: The Associate Director, Publications is a key Medical Affairs role which will administer development of publication plans, congress activities, and field medical materials at Ardelyx. This role will work closely with internal and external authors, and other stakeholders, to develop high-quality disease state and product-related abstracts, posters, and manuscripts. The Associate Director is responsible for the management of medical communications agencies and for ensuring on-time, high quality deliverables.

Requirements

Advanced degree in Life Sciences: PhD (preferred), PharmD, or MD with 5+ years of experience in scientific publications within Pharma/Biotech industry or medical communication agency or equivalent experience
In depth knowledge of ICMJE and GPP guidelines, proficiency in industry supported publications development process, CMPP certification preferred
Strong understanding of clinical trial conduct, real-world data generation and other data sources for publications such as SLRs, expert opinion articles
Ability to quickly and consistently build and maintain high level of trust and effectively collaborate with internal and external stakeholders
Demonstrated experience executing projects with competing priorities and tight deadlines
Strong ability to interpret, organize and communicate complex scientific data in a concise manner; ability to generate insights
Strong sense of urgency, project planning and management skills
Knowledge of pharmaceutical and promotional compliance guidelines, laws, industry standard practice, and applicable regulatory guidelines pertaining to medical content development
Demonstrated customer-centered approach

Responsibilities

Assist in creation of integrated scientific communication strategy and tactical publication plans for therapeutic areas in accordance with brand and medical strategies and incorporating modern digital channels and tools
Lead execution of tactical publication plans which entails publications development in timely, compliant manner following Ardelyx publications policy, ICMJE, and GPP guidelines
Partner effectively with internal and external authors, other internal stakeholders and medical communication agencies to complete publication milestones
Lead development of other audience (APPs, RDs, non-expert physicians, PCPs, patient advocacy outreach) tailored publication extenders including but not limited to infographics, plain language summaries, visual abstract, short audio/videos, and podcasts
Co-lead annual publication planning and quarterly publication team meetings
Maintain publication metrics and keep up with evolving metrics measure, serve as the point person with relevant medical affairs analytics partners
Lead planning, coverage and reporting of major and smaller specialty GI and Nephrology congresses.
Provide on-site support for Tier-1 conferences
Lead weekly literature surveillance, discussion forums, develop and distribute literature reports
Ensure alignment of the publications plan with all corporate policies and industry guidelines (ICMJE, GPP3)
Manage relationships with medical communications agencies