Principal Medical Writer

1 dzień temu

Warszawa, Mazovia, Polska Pharmiweb Pełny etat
Unlock Your Potential as a Principal Medical Writer

At Pharmiweb, we're seeking a highly skilled Principal Medical Writer to join our team. As a key member of our clinical development team, you'll play a crucial role in accelerating customer success by translating complex clinical, medical affairs, and commercial insights into actionable outcomes.

About the Role

As a Principal Medical Writer, you'll be responsible for mentoring and leading less experienced medical writers on complex projects, representing the Medical Writing department on clinical study teams, and advising clients and study teams on data presentation and production strategies. You'll also develop good working relationships with internal and external colleagues, manage medical writing activities associated with individual studies, and coordinate medical writing activities within and across departments with minimal supervision.

Key Responsibilities
  • Mentor and lead less experienced medical writers on complex projects
  • Represent the Medical Writing department on clinical study teams, at conferences, meetings, and for presentations to the client regarding a writing project
  • Advise clients and study teams on data presentation and production strategies and on data to ensure that client objectives/expectations are met and quality standards are maintained
  • Develop good working relationships with internal and external colleagues
  • Manage medical writing activities associated with individual studies, coordinating medical writing activities within and across departments with minimal supervision
  • Develop or support a variety of documents, including clinical study protocols, clinical study reports, patient narratives, clinical development plans, IND submissions, annual reports, integrated summary reports, NDA and (e)CTD submissions, investigator brochures, and clinical journal manuscripts
  • Review statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency
  • Serve as a peer reviewer, providing review comments to give maximum clarity of meaning, accuracy, relevance, and to ensure that client objectives are met and overall quality standards are maintained
  • Adhere to established regulatory standards, including ICH-E3 guidelines, as well as company SOPs, client standards, and company and/or client-approved templates when completing medical writing projects, on-time and on-budget
  • Perform online clinical literature searches, as applicable
  • Continuously develop professional skills to keep pace with regulatory guidance and client expectations that affect medical writing and to improve skills
  • Understand budget specifications for assigned projects, working within the budgeted hours and communicating changes to medical writing leadership
  • Complete required administrative tasks within the specified timeframes
Requirements
  • Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree (Social Sciences, English, or Communications, preferred) with relevant scientific and/or medical knowledge and expertise
  • Extensive knowledge of English grammar with a familiarity with AMA style guide
  • Understanding of FDA and ICH regulations and guidelines strongly preferred
  • Demonstrated effective presentation, proofreading, and interpersonal skills, and ensure a team-oriented approach
  • Strong proficiency in Word, Excel, PowerPoint, email, and Internet
  • Ability to demonstrate a familiarity with principles of clinical research and to interpret and present clinical data and other complex information
About Us

At Pharmiweb, we're passionate about developing our people, through career development and progression, supportive and engaged line management, technical and therapeutic area training, peer recognition, and total rewards programs. We're committed to our Total Self culture - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we're dedicated to taking care of our people. We're continuously building the company we all want to work for and our customers want to work with. When we bring together diversity of thoughts, backgrounds, cultures, and perspectives, we're able to create a place where everyone feels like they belong.

Join us in our mission to accelerate customer success and make a meaningful impact in the lives of others. Apply now to become a Principal Medical Writer at Pharmiweb

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