The Senior Medical Writer is responsible for providing medical and publication support to TFF Pharma (TFF). H/she will complete writing projects in collaboration with local and global cross-functional program teams. The Senior Medical Writer is responsible for ensuring that all documents are written in accordance with guidelines, SOPs, and applicable regulations.
Key Tasks & Responsibilities
• Provide medical writing and editing expertise and approval of clinical and regulatory documents.
• Author documents while contributing therapeutic expertise, knowledge/skills related to clinical drug development, and scientific/technical expertise.
• Learn and maintain therapeutic area and product knowledge and apply it to projects.
• Coordinate, synthesize, and integrate scientific and medical input from internal and external contributors to meet deliverable and publication deadlines for clinical documents, regulatory submissions, manuscripts, abstracts, presentations, etc.
• Provide medical writing and editing expertise for regulatory submission documents that include, but may not be limited to:
o clinical study protocols and clinical protocol amendments;
o clinical study reports;
o clinical development plans;
o IND submissions and annual reports;
o Integrated summary reports;
o NDA and (e)CTD submissions;
o investigator brochures,
o Development Safety Update Reports (DSUR)
o clinical journal manuscripts, clinical journal abstracts, and client presentations.
• Provide medical writing and editing expertise, while working with internal and external authors, to develop complex scientific manuscripts, abstracts, posters, oral presentations, medical information letters, and other printed materials to support the scientific communication of medical/ pharmaceutical products and study results.
• Understand and interpret data generated from a variety of sources, including internal and external studies, research documentation, charts, graphs, tables, and published literature.
• Maintain current awareness of good-publication practices and editorial policies and apply to publishing projects.
• Ensure publications and/or abstracts are drafted within the guidelines of selected journal.
• Adheres to established regulatory standards, including but not limited to ICH-E3 guidelines, as well as TFF Standard Operating Procedures, client standards, and TFF and/or client approved templates when completing medical writing projects, on-time and on-budget.
• Have in-depth knowledge about publication searching and management.
• Analyze, synthesize, and incorporate new and relevant medical literature into existing resource documents as needed. These documents include, but are not limited to, organizational customer/managed care group dossiers and formulary kits, standard medical and/or information response letters, etc.
• Direct or conduct systematic and comprehensive scientific literature reviews and compile assembled information into the requested format to support various clinical initiatives, including regulatory submissions and manuscripts.
• Coordinate the quality control review, approval, submission, and production of final documents, in accordance with established timelines, while independently addressing all document content issues. Maintain audit trail of changes.
• Effectively manage all assigned publication projects, including projects outsourced to vendors.
• Interact with department heads and staff members in data management, biostatistics, regulatory affairs, and clinical affairs as necessary to produce writing deliverables.
• Assist in the development, implementation and training of SOPs, templates or other best practices.
• Mentor and lead less experienced medical writers and/or contract writers on complex projects, as necessary, to ensure correct templates are used and quality is maintained.
• Additional tasks not described within to meet TFF requirements and milestones.
The above statements are intended to describe the general nature and level of work being performed by individuals assigned to this job. They are not intended to be an exhaustive list of all responsibilities, duties and skills required of the job. All employees may have other duties assigned at any time.
Bachelor’s degree preferably in Science, English, or Communications with relevant scientific experience required. MD, PhD, PharmD, or Master’s Degree highly preferred. American Medical Writing Association (AMWA) certification or other medical writing certification is preferred.
Professional Skills & Experience:
• Minimum of 5 years of medical-writing experience in the pharmaceutical and/or medical device, health sciences, or biotech industry including at least three (3) years of specific medical writing experience in the healthcare industry. Consideration will also be given to those with similar experience in the medical information or medical communication fields.
• Excellent verbal and written communication skills required.
• Native English speaker or proven level of excellent spoken and written English, including understanding of English language usage and standardized-writing styles.
• Strong interpersonal and teamwork skills.
• Able to work independently and proactively.
• Able to write presentations and articles for peer reviewed publications that conform to prescribed style and format.
• Understanding of mathematical concepts such as probability and statistical inference.
• Sound organizational and planning skills; deadline-oriented and meticulous in approach; and possess a sense of urgency and accuracy. Attention to detail is required.
• Able to work on multiple projects simultaneously, while maintaining competing priorities, timelines, and quality of deliverables.
• Must be able to anticipate obstacles and proactively develop solutions to achieve project goals.
• Ability to prioritize and plan workload is essential.
• Readily adaptable to changes in priorities.
• Able to interact productively with a variety of personalities and to work effectively in an international environment.
• Solid work ethic, professionalism, and sense of responsibility and personal accountability.
• Must be able to recommend improvements to existing templates or create templates for streamlining best practices and consistency.
• Excellent demonstrable understanding of FDA and/or EMEA regulations, GCP, ICH guidelines.
• Excellent computer skills, with experience using Microsoft Office (Word, Excel, Power Point) applications to prepare charts, tables, forms, reports, and presentations. Experience with e-mail and calendar programs required. Experience with authoring software, such as Author Bridge, EndNote, or Reference Manager is desirable.
• Experience in performing medical-database searches (e.g., Medline, PubMed, etc.).
Personal Skills & Competencies
• Ethics: treats people with respect, inspires the trust of others, demonstrates integrity.
• Leadership by example, with empathy and influence.
• Communication: listens and gets clarification, responds well to questions, speaks clearly and persuasively in positive and challenging situations.
• Teamwork: balances team and individual responsibilities, gives and welcomes feedback, contributes to building positive team spirit, puts success of team above own interests, supports everyone’s efforts to succeed.
• Analytical, pragmatic approach to problem solving.
Physical Demand/Work Environment
• The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
• In the typical office environment requirements include: reading, speaking, hearing, close vision, walking, bending, sitting, use hands and fingers (i.e. typing) and occasional lifting up to 20 pounds.
• There will be an occasional requirement to work outside of normal business hours.
• Occasional travel may be required (<5%).
• An individual in this position must be able to successfully perform the essential functions listed above.