[Hiring] Senior Principal Medical Writer @Syneos Health

Role Description

Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and the client authoring standards, as applicable, in adherence with study/project timelines and corporate objectives.

• Manage medical writing projects, including developing timelines (working with the study/project teams, as necessary) and communication with cross-functional team members to maintain awareness of review cycles and expectations.
• Participate in cross-functional meetings to provide input regarding medical writing deliverables, timelines, and any process(es) needed for the completion of regulatory documents.
• Review other documents associated with the assigned project(s) (e.g., Protocols and Statistical Analysis Plans), as appropriate.
• Participate in cross-functional process improvement initiatives.
• Participate in defining and writing standard operating procedures and best practices for an efficient preparation of quality documents.
• Manage internal and contract medical writing resources as required to ensure timely completion of assigned projects.
• Mentor more junior medical writing staff.

Qualifications

• Oncology experience preferred, but not required.
• Bachelor's degree required. Advanced degree in a relevant scientific/clinical/regulatory field preferred.
• At least 5 years of medical writing experience in the biopharmaceutical/CRO industry required or comparable experience within clinical or preclinical development.
• Proficiency in organizing and communicating clinical information required with minimal oversight.
• Strong organizational, time management, and project management skills are required.
• Strong verbal, written, and interpersonal communication skills needed to work effectively in a team environment.
• Proficient understanding and knowledge of global regulatory requirements needed and knowledge of therapeutic areas in all phases of clinical development desired.
• Proficient in MS Word. Experience with an electronic document management system and templates is required.

Benefits

• 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 building an inclusive culture – where you can authentically be yourself.
• We are continuously building the company we all want to work for and our customers want to work with.

Company Description

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.