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Principal Medical Writer - Single Sponsor - CTD Documents

Principal Medical Writer - Single Sponsor - CTD Documents

Syneos HealthDrammen, Viken, Norge
19 dager siden
Jobbeskrivelse

Principal Medical Writer - Single Sponsor - CTD Documents

Principal Medical Writer - Single Sponsor - CTD Documents

Syneos Health is a leading fully integrated biopharmaceutical solutions organization built to accelerate customer success. We translate unique clinical, medical affairs and commercial insights into outcomes to address modern market realities. Our Clinical Development model brings the customer and the patient to the center of everything that we do. We are continuously looking for ways to simplify and streamline our work to not only make Syneos Health easier to work with, but to make us easier to work for. Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you’ll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to accelerate the delivery of therapies, because we are passionate to change lives.

Overview of working at Syneos Health : we have 29,000 employees across 110 countries who know that work here matters everywhere.

  • We are 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 program.
  • We are committed to our Total Self culture – authentic you, united globally, with care for our people.
  • Diversity of thought, backgrounds, cultures, and perspectives helps us create a sense of belonging.

Responsibilities

  • Mentor and lead less experienced medical writers on complex projects as necessary.
  • Represent the Medical Writing department on clinical study teams, at conferences, meetings and for client presentations.
  • Advise clients and study teams on data presentation and production strategies to meet client objectives and maintain quality standards.
  • Develop good working relationships with internal and external colleagues.
  • Manage medical writing activities for individual studies, coordinating across departments with minimal supervision.
  • Develop or support documents including : clinical study protocols and amendments; clinical study reports; patient narratives; clinical development plans; IND submissions and annual reports; integrated summary reports; NDA and (e)CTD submissions; investigator brochures; clinical journal manuscripts and abstracts; client presentations.
  • Review statistical analysis plans and table / figure / listing specifications for content, grammar, format, and consistency.
  • Provide peer review feedback to ensure clarity, accuracy, relevance and client objectives are met.
  • Adhere to regulatory standards (ICH-E3), SOPs, client standards, and approved templates; deliver on time and on budget.
  • Perform online clinical literature searches as applicable.
  • Pursue ongoing professional development to align with regulatory guidance and client expectations.
  • Understand budget specifications and work within allocated hours, communicating changes to leadership.
  • Complete required administrative tasks within specified timeframes.
  • Performs other work-related duties as assigned. Minimal travel may be required (less than 25%).
  • Qualifications

  • Bachelor’s degree or RN in a related field or equivalent experience
  • Ability to lead and align teams to achieve project milestones
  • Capable of working in an international environment
  • Previous clinical trial experience in site management
  • Preferred experience with risk-based monitoring and clinical or central monitoring
  • Familiar with financial principles and budget management
  • Knowledge of Good Clinical Practice / ICH Guidelines and other regulatory requirements
  • Strong computer skills
  • Good communication, presentation and interpersonal skills across project teams and sites
  • Basic conflict resolution skills
  • Problem-solving ability with risk management for clinical research projects
  • Demonstrates critical thinking to identify issues and determine appropriate solutions
  • Moderate travel may be required, approximately 20%
  • Get to know Syneos Health

    Over the past 5 years, we have worked with 94% of all Novel FDA Approved Drugs, 95% of EMA Authorized Products and over 200 studies across 73,000 sites and 675,000+ trial patients.

    No matter what your role is, you’ll take the initiative and challenge the status quo with us in a highly competitive and ever-changing environment. Learn more about Syneos Health at .

    Additional Information

    Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company may assign other tasks at its sole discretion and with no prior notice. Equivalent experience, skills, and / or education will be considered. The Company will determine what constitutes an equivalent qualification. Nothing herein should be construed as an employment contract. The Company complies with applicable laws, including the EU Equality Directive and the Americans with Disabilities Act, with reasonable accommodations as appropriate.

    Seniority level

  • Mid-Senior level
  • Employment type

  • Full-time
  • Job function

  • Marketing, Public Relations, and Writing / Editing
  • Referrals increase your chances of interviewing at Syneos Health. Get notified about new Medical Writer jobs in Drammen, Viken, Norway.

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