Medical Writer (FHI Clinical) - Remote (South Africa)

FHI 360 staff working in the United States are required to be fully vaccinated for COVID-19, regardless of the type of project or client they serve, or of their employment status (full/part-time, remote, telework, or in-office), unless an accommodation applies. FHI 360 complies with federal, state, and local laws with regard to accommodations related to this policy.

The Medical Writer is tasked with the writing of trial-related documentation for clinical projects undertaken by the Company, in accordance with ICH GCP and local legal requirements, European, FDA, and other international guidelines, as well as Company (and sponsor, if applicable) SOPs.

Write, or coordinate the writing of appropriate sections of:

• Protocols and protocol amendments

• Clinical study reports, addenda, and synopses

• Collation of finalized clinical study reports

• Investigator's Brochures

• Safety update reports

• Publications

• Statistical reports (aid the biostatistician)

• Document formatting and editing, where required

• Other documents in accordance with contractual requirements

• Expert medical/scientific writing skills

• Uncompromising attention to detail and the ability to think analytically

• Able to communicate in English, effectively and accurately, both orally and in writing

• Effective time management skills

• Ability to prioritize workload

• Excellent interpersonal skills and problem-solving ability

• Diplomatic conflict management

• Effective organizational and negotiation skills

• Strong computer skills, with the ability to learn appropriate software as necessary

• Proficient knowledge of human physiology

• Basic knowledge of pharmacology areas

• Proficient knowledge of therapeutic areas

• Proficient knowledge of all relevant Company SOPs, ICH GCP and local legal requirements, European, FDA, and other relevant international guidelines applicable to clinical research

• Education: Bachelor's or higher graduate degree in a medically related scientific field

• Preferred Job-related Experience: A minimum of three years of demonstrated medical scientific/medical writing experience. Experience in clinical research and protocol development would be an advantage

• Typical office environment

• Ability to sit or stand for extended periods of time

• Ability to lift or push 5-15 lbs

• Expected travel time is less than 10% for this position.

This job description is not designed to cover or contain a comprehensive listing of activities, duties or responsibilities that are required of the employee. Duties, responsibilities, and activities may change, or new ones may be assigned with or without notice.

FHI Clinical, Inc. provides equal employment opportunities to all employees and applicants for employment without regard to race, color, ancestry, national origin, gender, sexual orientation, marital status, religion, age, disability, gender identity, results of genetic testing, or service in the military.

This job posting summarizes the main duties of the job. It neither prescribes nor restricts the exact tasks that may be assigned to carry out these duties. This document should not be construed in any way to represent a contract of employment. Management reserves the right to review and revise this document at any time.

FHI 360 is an equal opportunity and affirmative action employer whereby we do not engage in practices that discriminate against any person employed or seeking employment based on race, color, religion, sex, sexual orientation, gender identity, national or ethnic origin, age, marital status, physical or mental disability, protected Veteran status, or any other characteristic protected under applicable law.

FHI 360 will consider for employment all qualified applicants, including those with criminal histories, in a manner consistent with the requirements of applicable state and local laws.

FHI 360 fosters the strength and health of its workforce through acompetitive benefits package, professional developmentand policies and programs that support a healthy work/life balance. Join our global workforce to make a positive difference for others - and yourself.

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