Sponsor Dedicated Sr Principal Medical Writer - Must have Regulatory document Submissions experience

Description

Senior Principal Medical Writer

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.

Why Syneos Health

1. 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.
2. 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.
3. 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

• Responsible for the development of clinical documents for submissions to regulatory authorities globally.
• Oversees the medical writing activities of multiple compounds and serves as lead writer for individual summary documents.
• Mentors and leads less experienced medical writers on complex projects, as necessary.
• Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, internal authoring standards, as applicable, in adherence with study/project timelines and corporate objectives.
• Lead, manage, and coordinate all internal and external clinical medical writing activities associated with the preparation, compilation, and submission of applications to regulatory authorities globally for the assigned programs/compounds.
• Develops good working relationships with internal and external colleagues.
• Lead or participate in cross-functional process improvement initiatives.
• Develops or supports a variety of documents that include but not limited to:
  1. Clinical study protocols and clinical protocol amendments;
  2. Clinical study reports;
  3. Patient narratives;
  4. Clinical development plans;
  5. IND submissions and annual reports;
  6. Integrated summary reports;
  7. NDA and (e)CTD submissions;
  8. Investigator brochures;
  9. Clinical journal manuscripts, clinical journal abstracts, and client presentations.
• Reviews statistical analysis plans and table/figure/listing specifications for appropriate content, and for grammar, format, and consistency.

Qualifications
What we’re looking for

• Bachelor of Science degree with relevant writing experience or Bachelor of Arts degree.
• Solid Principal Medical Writer with experience gained from a CRO or Pharma.
• Excellent project management skills including in depth understanding of clinical timelines (study and submission level) and working knowledge of roles of other functional areas and the interdependencies among groups.
• Strong verbal, written, and interpersonal communication skills needed to work effectively in a team environment.
• Proficient understanding and knowledge of global regulatory requirements is needed and knowledge of therapeutic areas in all phases of clinical development desired.
• 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.

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.

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. #J-18808-Ljbffr