Senior Medical Writer, Cardio/Metabolic Health

For the past 25 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R&D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de‑risk and accelerate our partners’ most high‑profile drug and device programs. Essential Functions With minimal supervision, author (write/edit) high‑quality medical writing deliverables (e.g., clinical, safety, regulatory, device, diagnostics, or disclosures documents) across all phases of clinical research and in various therapeutic areas including protocols, protocol amendments, study reports, patient narratives, IBs, ICFs, CEPs/CERs, DSURs, and plain language summaries, as well as more complex documents (e.g., PBRER, IND, NDA, BLA, MAA, eCTD submission‑level documents). Supervise and mentor less‑experienced medical writers, as necessary. Adhere to established regulatory standards/guidelines such as ICH E3/E6(R2), EU MDR/IVDR, company standard operating procedures, client standards, and company‑ and/or client‑approved templates. Strive to complete medical writing deliverables on time and within budget. With minimal supervision, manage client expectations, interact and communicate directly with clients, lead team meetings (e.g., project kickoff, comment review), and manage deliverable timelines. Interact and collaborate with subject matter experts in clinical operations, data management, biostatistics, regulatory affairs, etc., as needed, to produce writing deliverables. Coordinate QC reviews of documents and maintain audit trails of changes as applicable. Review statistical analysis plans and table/figure/listing shells for appropriate content, grammar, format, and consistency. If requested by supervisor, perform QC review (e.g., review in‑text tables against statistical output). Perform peer review of documents written by other medical writers, as required. Assist with project‑related administrative tasks (e.g., create and maintain timelines, update deliverable trackers, host internal/client meetings). Maintain familiarity with current industry practices, regulatory requirements, and guidelines related to medical writing. Understand budget specifications for assigned deliverables, work within the budgeted hours, and communicate out‑of‑scope tasks to medical writing leadership. Support multiple medical writing deliverables/projects simultaneously and manage own workload with minimal intervention from management team. Bring issues and potential concerns to line manager/client oversight manager’s attention and propose possible solutions for consideration by management team. Participate in departmental initiatives (e.g., process improvement, lunch and learns, etc.). Other duties as assigned. Necessary Skills and Abilities Advanced knowledge of clinical research principles and demonstrated ability to interpret and present clinical data and other complex information. Advanced understanding of FDA (and other regulatory bodies as relevant to their role) and applicable regulations and guidelines. Advanced understanding of regulatory submission requirements and processes. Proficiency with computer technology and expert word‑processing skills in MS Word, including required proficiency with tables, graphs, and figures. Exceptional project management skills and strong communication skills with a high attention to detail and quality. English language proficiency and familiarity with American Medical Association (AMA) style. Strong experience in relationship building and strategic collaboration on key business accounts. Think proactively, take initiative, and willingly take on new challenges. Ability to identify areas of concern or inefficiency and propose solutions for consideration by the management team to improve overall efficiency and quality of deliverables. Work independently with exceptional time‑management skills and contact management team proactively when additional support and resources are needed. Work effectively in a collaborative team environment. Demonstrate a growth mindset and positive outlook in all work activities. Educational Requirements Bachelor’s degree or higher, preferably in medical or scientific discipline. Experience Requirements Minimum of 5 years of experience in writing clinical and/or regulatory documents for drugs, biologics, and/or medical devices/diagnostics for a contract research organization, pharmaceutical company, or biotechnology company. Other professional and/or educational experience may contribute toward this minimum requirement, as determined on a case‑by‑case basis. We celebrate our differences and strive to create a workplace where each person can be their authentic self. We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed. All applications to roles at ProPharma are personally reviewed by a member of our recruitment team. We do not rely on AI screening tools to support our hiring process. You will always receive an outcome to your application so that you have an answer from us – whether you’re successful or not. Whilst ProPharma supports remote working, we also recognize the value that comes from in‑person collaboration. As such, we encourage any new hires that are based within a reasonably short commute of one of our offices to work on a hybrid basis and spend some time working from that office location, as agreed with your manager. All applications will be treated on their own merit and candidates will not be at any advantage or disadvantage based on their proximity to an office. ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting. #J-18808-Ljbffr