Washington, DC 20001
Location: Washington, DC
Company: Top BioPharma Company
Compensation: $115K to $125k Base + Bonus + Stocks + Pension + Amazing Benefits
Contact: Ken Kupersmith- [email protected]
***Serious Inquiries Only: If you apply and do not meet the below requirements you will not be contacted or considered***
* At least 2 years Medical Publications Experience (writing and editing skills from Pharma/Biotech, Medical Communications Agency, CRO or Academic setting)
* Strong Cross-functional Collaboration Skill
* Doctorate required (PhD, PharmD, MD)
Responsible for the development, management, and execution of strategic publication plans and high-quality clinical publications for investigational pipeline and/or marketed products in Cardiovascular and Metabolic Disease therapeutic area. Responsible for ensuring publications plans and deliverables comply with company publication policies and external publication guidelines, and that publications represent a transparent and fair balance communication of data.. Manages cross-functional teams in the development and execution of strategic publication plans in alignment with strategy and objectives.
o Serves as key contact for all publication-related activities for assigned programs.
o Oversees the entire publication development process to deliver high-quality publications.
o Ensures that strategically aligned scientific communication points are delivered and that statements and conclusions in publications are accurate and supported by appropriate data.
o Oversees the publication sign-off process (PSO), including publication tracking and documentation through the e-publication system, ensuring compliance with internal polices and external publication guidelines.
o Responsible for reporting publication metrics and project status reports to cross-functional teams and management.
o Works with/Manages vendors, internal medical writers and contract resources in the development of publications and strategy plans, effectively using project management skills.
o Ensures the high quality and transparency of publications by maintaining/promoting familiarity with ICMJE, GPP3, CONSORT, AMA, and other external standards as well as internal publication policies and procedures.
o Requires 2 to 4 years of experience in medical communications/publications in pharmaceutical/biotech industry, medical communications agency, CRO, or academic setting.
o Strong publications and/or project management skills required.
o Working knowledge of overall drug development process, including stages of development and role of different functional areas required.
o Thorough understanding of publication strategy and planning strongly preferred.
o Previous experience writing and editing peer-reviewed clinical publications highly desirable.
o Previous experience with management of contract resources/vendors required.
o Requires PhD, PharmD or MD degree with proven scientific and/or publications expertise.
o AMWA, BELS, Project Management, and/or ISMPP certification a plus.
o Knowledge/Understanding of GPP3, ICMJE, AMA, and other publication standards helpful.
o Demonstrates flexibility while supporting multiple projects, dealing effectively with change and ambiguity, and prioritizing deadlines; ability to establish and maintain professional relationships with external experts, investigators, journal editors, publishers, and professional bodies.
o Ability to analyze critically and synthesize scientific information from a broad range of scientific disciplines and clinical therapeutic areas.
o Strong attention to detail and problem-solving skills
o Proficiency in Microsoft Office applications (Word, Excel, PowerPoint) required; working knowledge of electronic publication system strongly preferred.