Principal 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:
Ensures appropriate communicationon project-and program-related matters with medical writing leadership, internal functional area heads, and internal resources/consultantsas applicable.
Manages clinical program documents for assigned clients, such as protocols, protocol amendments, IBs, ICFs, patient narratives, study reports, as well asmore complex regulatory documents (e.g., PBRER, IND, NDA, BLA, MAA, eCTD submissionleveldocuments)as assigned.
Leads cross-functional coordination of resources (e.g., internal resources/consultants) to manage medical writing and QC deliverablesas assigned.
Independentlyauthors (writes/edits) high-quality medical writing deliverables (i.e.,clinical, safety, regulatory, device, diagnostics, or disclosures documents)acrossall phases of clinical research and in various therapeutic areas including but not limited to: protocols, protocol amendments, study reports, patient narratives, IBs, ICFs, CEPs/CERs, DSURs, and plain languagesummaries, as well asmore complex documents (e.g., PBRER, IND, NDA, BLA, MAA, eCTD submissionlevel documents).
Supervises, trains,and mentors less experienced medical writers, as necessary.
Adheres to established regulatory standards/guidelinesincluding but not limited to: ICH E3 orE6(R2), EU MDR/IVDR, Company standard operating procedures, client standards, and Company- and/or client-approved templates.
Strives to complete medical writing deliverables on time and within budget.
Independently manages client expectations and interactsand communicates directly with clients, leads team meetings (e.g., project kickoff,comment review), and manages the deliverable timelines.
Interacts and collaborates with subject matter experts in clinical operations, data management, biostatistics, regulatory affairs, etc., as needed, to produce medical writing deliverables.
Coordinates QC reviews of documents and maintainsaudit trails of changesas applicable.
Reviews statistical analysis plans and table/figure/listing shells(as applicable)for appropriate content, grammar, format, and consistency.
If requested by supervisor, performs QC review (e.g., reviews in-text tables against statistical output).
Performs peer review of documents written by other medical writers, as required.
Assistswith project-related administrative tasks (e.g., creates and maintainstimelines, updates deliverable trackers, hosts internal/client meetings).
Maintains familiarity with current industry practices, regulatory requirements, and guidelines related to medical writing.
Understands budget specifications for assigned deliverables, works within the budgeted hours, and communicates out-of-scope tasks to medical writing leadership.
Supports multiple medical writing deliverables/projects simultaneously and manages own workload with minimal intervention from management team.
Brings issues and potential concerns to line manager/client oversight manager’s attention and proposes possible solutionsfor consideration by management team.
Participates in and leads 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 demonstratedability 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.
Computer technology proficiencyand expert word processing skills in MS Word, including required proficiencywith tables, graphs, and figures.
Exceptional project management skills and strong communicationskills with a high attention to detail and quality.
English language proficiencyand familiarity with American Medical Association (AMA) style.
Strong experience in relationship building and strategic collaboration on key business accounts.
Thinks proactively, takes initiative, and willingly takes on new challenges.
Ability to identifyareas of concern or inefficiency and propose solutions for consideration by the management team to improve overall efficiency and quality of deliverables.
Works independently with exceptional time-management skills and contacts management team proactively when additionalsupport and resources are needed.
Works effectively in a collaborative team environment.
Demonstrates 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 7years of experience in writing clinical and/or regulatory documents for drugs, biologics, and/or medical devices/diagnosticsfor a contract research organization, pharmaceutical company, or biotechnology company.
Other professional and/or educational experience may contribute toward this minimumrequirement, as determinedon a casebycasebasis.
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 recognise 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.***