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Medical Communications Postdoctoral Fellowship

Education
Doctorate

Location
Gaithersburg, MD

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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.
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.
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.
Date Posted
25-May-2018 Closing Date

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