Principal Medical Writer (FHI Clinical) Full-time Job

he Principal 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) Procedural Documents. Complete medical/scientific writing assignments, as required for clinical projects undertaken by the Company.

Take a leading role in preparing assigned documents, which includes but is not limited to, confirming the scope of the task, confirming templates and specifications, negotiating and adhering to timelines, organizing document reviews and communicating directly with the client on medical writing-related issues as they arise.

Coordinate information and data inputs from team members when preparing trial documents. Independently plan and organize workload for assigned projects and tasks, identify project needs, track timelines and implement customer requests.

Essential Functions:

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.

Investigators Brochures.

Safety update reports.

Publications.

Statistical reports (provide assistance to the biostatistician).

Document formatting and editing, where required.

Other documents in accordance with a contractual requirement

Knowledge, Skills and Abilities:

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.

Position Requirements:

Education: Bachelors or higher graduate degree in a medically related scientific field.

Preferred Job-Related Experience: A minimum of seven years of demonstrated medical scientific/medical writing experience. Adequate experience in clinical research.

Physical Expectations:

Typical office environment.

Ability to sit or stand for extended periods of time.

Ability to lift or push 5-15 lbs.

Travel Requirements:

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 a competitive benefits package, professional development and policies and programs that support a healthy work/life balance. Join our global workforce to make a positive difference for others and yourself.

FHI 360 is a nonprofit human development organization dedicated to improving lives in lasting ways by advancing integrated, locally driven solutions. Our staff includes experts in health, education, nutrition, environment, economic development, civil society, gender, youth, research, technology, communication and social marketing creating a unique mix of capabilities to address today's interrelated development challenges. FHI 360 serves more than 60 countries and all U.S. states and territories.As we evolve to meet the challenges of the future, we stand committed to the principles that have guided our organization for the last 40+ years. Our work continues to be grounded in research and science, strengthened by partnerships and focused on building the capacity of individuals, communities and countries to succeed.