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Principal Medical Writer (Publication and Content development)

Principal Medical Writer (Publication and Content development)

Syneos Health / inVentiv Health Commercial LLCSioux Falls, SD, United States
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Principal Medical Writer (Publication and Content development)

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.

Discover what our 29,000 employees, across 110 countries already know :

WORK HERE MATTERS EVERYWHERE

Why Syneos Health

  • 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 - where you can authentically be yourself. Our Total Self culture is what unites us globally, and we are dedicated to taking care of our people.
  • We are continuously building the company we all want to work for and our customers want to work with. Why? Because when we bring together diversity of thoughts, backgrounds, cultures, and perspectives - we're able to create a place where everyone feels like they belong.

Job Responsibilities

Publication Strategy & Planning

  • Execute scientific communication plans efficiently and effectively.
  • Assist in developing scientific messaging and maintaining Scientific Communication Platforms.
  • Facilitate alignment across teams to unify messaging and strategies, ensuring gaps are identified and addressed.
  • Ability to quickly develop expert knowledge of product and disease-specific literature
  • Conduct literature and gap analyses to support scientific message development and publication strategies.
  • Organize and facilitate expert meetings for publication strategy development, collaborating with MDs to prepare agendas, manage vendors, and present as needed.
  • Support and attend scientific congresses, advisory board meetings, and similar events.
  • Orchestrate the external / independent development of treatment and management guidelines. Publication Content Creation
  • Research, draft, and edit scientific and medical manuscripts, abstracts, posters, and presentations.
  • Review statistical analysis plans and table / figure / listing specifications for accuracy, grammar, format, and consistency.
  • Manage agency and / or contract medical writers and graphic designers as needed.
  • Ensure all scientific communications meet the highest standards of medical and scientific integrity.
  • Adhere to authorship and publication guidelines as stipulated by ICMJE and GPP 2022, as well as company SOPs and client standards.
  • Assist with publication development database maintenance and reconciliation activities. Other Responsibilities
  • Respond to internal and external inquiries regarding scientific communications in the product area.
  • Participate in cross-functional team meetings, providing status updates and issues regarding scientific communication planning and insights on publication strategies.
  • Provide support for managing the Scientific Communications budget.
  • Offer training, support, and consultation to department and company employees as needed.
  • Serve as a subject matter expert, developing training materials and presentations on key topics.
  • Mentor and lead less experienced medical writers on complex projects.
  • Perform additional work-related duties as assigned, with minimal travel required (less than 25%).
  • Qualifications

  • 5 or more years of relevant experience in scientific communications, publication planning and / or medical writing . Extensive knowledge of English grammar with a familiarity with AMA style guide.
  • Experience in rare metabolic conditions an advantage
  • 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.
  • At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions / bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

    Salary Range :

    $95,000.00 - $175,700.00

    The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.

    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.

    http : / / www.syneoshealth.com

    Additional Information

    Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and / or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills / experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.

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