Principal Medical Writer (FHI Clinical) at FHI360 NGO

Summary of the Position:

The 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.
• Investigator’s 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: Bachelor’s 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.