Senior Medical Writer I
Summary of The Position:
The Senior Medical Writer is tasked with the writing of study-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 client, if applicable) SOPs. The Senior Medical writer will complete scientific/medical writing assignments, as required for clinical projects undertaken by the Company, taking a lead role with limited guidance from senior members within the team. The Senior Medical Writer will be responsible for 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, as well as coordinate information and data inputs from team members when preparing study documents. The Senior Medical Writer is responsible for independently planning and organizing workload for assigned projects and tasks, identifying project needs, tracking timelines, and implementing customer requests.
Write and/or coordinate the writing of appropriate sections of:
Protocols and Protocol Amendments (including full synopsis and document development, synopsis and document development assistance, and synopsis and document review).
Informed Consent Forms
Clinical study reports (including full, interim and/or final, abbreviated, synoptic, addenda, etc.) including Appendices and safety narratives, and final collation and publishing of the final documents.
Review and provide input into the SAP and mock and draft TFLs.
Annual Safety Update Reports (including DSURs, PSURs etc.).
All contracted submission-ready documents as per Regulatory Authority requirements (e.g., Modules 1 through 4 [administrative, quality, nonclinical, and clinical documents])
Development and/or review of any other document in accordance with contractual requirements.
Maintain quality control, formatting, and editing of assigned documents.
Perform quality control of documents assigned to other Medical Writings (including reviewing data, data integrity, interpretation, and ensuring formatting and style guides as per FHI Clinical standards (or client if requested) and ultimate quality standards per industry and FHI Clinical requirements.
Knowledge, Skills, and Abilities:
Mindset for learning.
Expert scientific/medical 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, including:
Microsoft Teams, including Sharepoint sites through Teams and ability to work collaboratively on documents.
Smartsheet or other timeline management systems.
Ability to learn and improve on 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 (or its international equivalent) in a scientific-/medically-related field.
Preferred Job-related Experience: A minimum of 3 years of demonstrated Regulatory Medical Writing experience. Adequate experience in clinical research.
Typical office environment.
Ability to sit or stand for extended periods of time.
Ability to move 5-15 lbs.; or 2.26 - 6.8 kg.
Expected travel time is less than 10 % for this position.
This job description is not intended 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. and its subsidiary and affiliate companies provide 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.
Our values and commitments to safeguarding: FHI 360 is committed to preventing any type of abuse, exploitation and harassment in our work environments and programs, including sexual abuse, exploitation and harassment. FHI 360 takes steps to safeguard the welfare of everyone who engages with our organization and programs and requires that all personnel, including staff members and volunteers, share this commitment and sign our code of conduct. All offers of employment will be subject to appropriate screening checks, including reference, criminal record and terrorism finance checks. FHI 360 also participates in the Inter-Agency Misconduct Disclosure Scheme (MDS), facilitated by the Steering Committee for Humanitarian Response. In line with the MDS, we will request information from job applicants’ previous employers about any substantiated findings of sexual abuse, exploitation and/or harassment during the applicant’s tenure with previous employers. By applying, job applicants confirm their understanding of these recruitment procedures and consent to these screening checks.
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.
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