Associate Director, Principal Medical Writer II (FSP, W2, Salary) Position Available In Wake, North Carolina

For the past 20 years, ProPharma has improved the health and wellness of patients by providing advice and expertise that empowers biotech, med device, and pharmaceutical organizations of all sizes to confidently advance scientific breakthroughs and introduce new therapies. ProPharma partners with its clients through an advise-build-operate model across the complete product lifecycle. With deep domain expertise in regulatory sciences, clinical research solutions, quality & compliance, pharmacovigilance, medical information, and R D technology, ProPharma offers an end-to-end suite of fully customizable consulting solutions that de-risk and accelerate our partners’ most high-profile drug and device programs. The Associate Director, Principal Medical Writer II is responsible for the development of clinical documents for submissions to regulatory authorities globally. Provides strategic direction to cross-functional project teams with minimal oversight to ensure that clinical documents (eg, Investigators’ Brochures [IBs], Clinical Study Reports [CSRs], and marketing authorization submission documents) accurately and consistently present key data-driven clinical messages in accordance with program goals and regulatory requirements. Writes or provides direction and leadership to other writers to ensure the timely delivery of high quality documents that are scientifically rigorous, logically organized, and have accurate data presentation and interpretation. Oversees the medical writing activities of multiple compounds and serves as lead writer for individual summary documents. Has a broad understanding of clinical research processes and global regulatory document standards. Mentors less experienced writers. Reports to a Director of Medical Writing or above.

Essential Functions:

• Develop regulatory documents for submission to regulatory agencies globally, in accordance with ICH and other global guidelines, standards and processes, and Incyte 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.
• 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) (eg, Protocols and Statistical Analysis Plans), as appropriate.
• Lead or participate in cross-functional process improvement initiatives.
• Lead or participate in defining and writing standard operating procedures and best practices for an efficient preparation of quality documents.
• Mentors more junior medical writing staff.

Qualifications:

• Bachelor’s degree required. Advanced degree in a relevant scientific/clinical/regulatory field preferred.
• At least 7 years medical writing experience in the biopharmaceutical/CRO industry required or comparable experience within clinical or preclinical development.
• Demonstrated ability to understand and interpret clinical and scientific data with minimal oversight; ability to define data presentation to meet key messages developed by the clinical team.
• 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 We celebrate our differences and strive to create a workplace where each person can be their authentic self.

We are committed to diversity, equity, and inclusion. Employees are encouraged to unleash their innovative, collaborative, and entrepreneurial spirits. With a holistic approach as an Equal Opportunity Employer, we provide a safe space where all employees feel empowered to succeed.

• ProPharma Group does not accept unsolicited resumes from recruiters/third parties. Please, no phone calls or emails to anyone regarding this posting.
• Don’t see an open opportunity that matches your qualifications?

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