Demo

ProPharma is hiring: Principal Medical Writer in Raleigh

ProPharma
Raleigh, NC Full Time
POSTED ON 2/7/2025
AVAILABLE BEFORE 4/29/2025

For the past 20 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. As the world’s largest RCO (Research Consulting Organization), 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 communication on project - and program-related matters with medical writing leadership, internal functional area heads, and internal resources / consultants as applicable.
  • Manages clinical program documents for assigned clients, such as protocols, protocol amendments, IBs, ICFs, patient narratives, study reports, as well as more complex regulatory documents (e.g., PBRER, IND, NDA, BLA, MAA, eCTD submission level documents) as assigned.
  • Leads cross-functional coordination of resources (e.g., internal resources / consultants) to manage medical writing and QC deliverables as assigned.
  • Independently authors (writes / edits) high-quality medical writing deliverables (i.e., clinical, safety, regulatory, device, diagnostics, or disclosures documents) across all 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 language summaries, as well as more complex documents (e.g., PBRER, IND, NDA, BLA, MAA, eCTD submission level documents).
  • Supervises, trains, and mentors less experienced medical writers, as necessary.
  • Adheres to established regulatory standards / guidelines including but not limited to : ICH E3 or E6(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 interacts and 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 maintains audit trails of changes as 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.
  • Assists with project-related administrative tasks (e.g., creates and maintains timelines, 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 solutions for 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 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.
  • Computer technology proficiency 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.
  • Thinks proactively, takes initiative, and willingly takes 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.
  • Works independently with exceptional time-management skills and contacts management team proactively when additional support 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 7 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.

    J-18808-Ljbffr

    If your compensation planning software is too rigid to deploy winning incentive strategies, it’s time to find an adaptable solution. Compensation Planning
    Enhance your organization's compensation strategy with salary data sets that HR and team managers can use to pay your staff right. Surveys & Data Sets

    What is the career path for a ProPharma is hiring: Principal Medical Writer in Raleigh?

    Sign up to receive alerts about other jobs on the ProPharma is hiring: Principal Medical Writer in Raleigh career path by checking the boxes next to the positions that interest you.
    Income Estimation: 
    $148,522 - $196,985
    Income Estimation: 
    $199,124 - $271,136
    Income Estimation: 
    $92,784 - $118,888
    Income Estimation: 
    $114,936 - $149,187
    Income Estimation: 
    $187,855 - $249,378
    Income Estimation: 
    $148,522 - $196,985
    Income Estimation: 
    $254,209 - $340,014
    Income Estimation: 
    $362,566 - $445,758
    View Core, Job Family, and Industry Job Skills and Competency Data for more than 15,000 Job Titles Skills Library

    Job openings at ProPharma

    ProPharma
    Hired Organization Address Raleigh, NC Contractor
    Regulatory CMC Consultant Therapeutic Area: Infectious Disease Draft Submissions Support CMC Responsibilities Lead proje...
    ProPharma
    Hired Organization Address Raleigh, NC Full Time
    For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that...
    ProPharma
    Hired Organization Address Raleigh, NC Part Time
    For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that...
    ProPharma
    Hired Organization Address Raleigh, NC Full Time
    For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that...

    Not the job you're looking for? Here are some other ProPharma is hiring: Principal Medical Writer in Raleigh jobs in the Raleigh, NC area that may be a better fit.

    AI Assistant is available now!

    Feel free to start your new journey!