Post Doctoral Medical Communications

Gaithersburg, Maryland, US
Nov 08, 2017
Nov 14, 2017
Medicine, Medical
Contract Type
Full Time
Job Type
The Medical Communications Postdoctoral Fellowship program is designed to provide PhDs or PharmDs with the opportunity to gain specialized and in-depth training in writing various regulatory documents and scientific publications related to clinical development within the pharmaceutical/biotechnology industry. Major Duties and Responsibilities: •       Assist in the development of high-quality clinical regulatory and other supporting documents for pipeline and/or marketed products. These documents may include: clinical study protocols, Investigator's Brochures, clinical study reports, and sections of Investigational New Drug (IND) Applications or Biologics License Applications (BLAs) •       Assist in the development of high-quality abstracts, posters, and manuscripts •       Learn about development and execution of a publication plan •       Work collaboratively with internal medical communication personnel, publications leads, publication  associates, and clinical study teams to ensure that projects are completed per time and quality goals •       Interact with external contract medical writers, investigators, journals, and colleagues in relevant professional associations •       Attend project-specific team meetings •       Develop a working knowledge of internal standard operating procedures (SOPs) as well as regulatory authority guidelines and requirements, International Conference on Harmonisation (ICH) Guidances, and International Committee of Medical Journal Editors (ICMJE) Recommendations for reference in the development of required clinical documents and publications •       Attend all relevant training courses and/or workshops (internal or external) to enhance professional development Education Requirements: A PhD in a Biomedical Sciences discipline or a PharmD is required. The candidate must have completed his/her doctoral degree requirements recently (ie, within the last 1-2 years). Candidates with one or two years of prior postdoctoral research experience will also be considered. Other Skills and Qualifications: The candidate must have: •       Conducted research in a relevant scientific field (eg, life sciences, pharmacology, pharmacokinetics/pharmacodynamics, health services research, or toxicology) •       Demonstrated interest and skills in scientific writing (e.g., manuscripts, research grants, etc); a good publication record and first authorship is a plus •       General understanding of statistical methodology •       Ability to learn and understand regulatory requirements and drug development processes •       Strong written, verbal, and interpersonal communication skills •       High attention to detail •       Willingness and ability to work collaboratively in a team environment •       Willingness and flexibility to adapt to changing deadlines and priorities •       Knowledge of Microsoft Office applications Next Steps - Apply today! To be considered for this exciting opportunity, please complete the full application on our website at your earliest convenience - it is the only way that our Recruiter and Hiring Manager can know that you feel well qualified for this opportunity.  If you know someone who would be a great fit, please share this posting with them. AstraZeneca is an equal opportunity employer. AstraZeneca will consider all qualified applicants for employment without discrimination on grounds of disability, sex or sexual orientation, pregnancy or maternity leave status, race or national or ethnic origin, age, religion or belief, gender identity or re-assignment, marital or civil partnership status, protected veteran status (if applicable) or any other characteristic protected by law .  AstraZeneca only employs individuals with the right to work in the country/ies where the role is advertised.