Director Scientific Writing
Regeneron is looking for a highly motivated Director of Scientific Writing and Regulatory Liaison (SWRL) to be responsible for leading a team of Writers and developing its staff. You will be a recognized leader in the company who will manage and communicate timelines and supervise SWRL deliverables. You work cross-functionally to help establish deliverables and timelines, and ensure they are clearly communicated and assigned appropriately. You are responsible for managing resources and hiring both in-house and contract staff to complete all assignments. You are expected to produce department guidelines, templates, standard timelines and SOPs that follow regulatory guidelines. They will be responsible for ensuring adherence to said guidelines templates, timelines, and SOPs for all documents, as appropriate, and you are responsible for the management and development of staff, including performance management, and training.A Typical Day in This Role Looks Like:
- Provide writing expertise, leadership, project management support and strategic input on documentation preparation and submissions.
- Optimize writing processes within SWRL team and key stakeholders.
- Build strategic partnerships and develop a strong knowledge of key resources available within the organization.
- Collaborate with multiple business functions including but not limited to: Program Management groups, Medical Writing, Regulatory Affairs and Clinical Development to ensure all deliverables are agreed upon and completed on time.
- Collaborate effectively with cross functional leaders and Subject Matter Experts to design optimal cross-functional solutions.
- Determines resource allocations to meet timelines, identifying resource capabilities and potential issues.
- Represents SWRL at cross-functional and cross-company meetings.
- Oversees/Leads Regulatory Submission document writing
- Drives meetings, actions, and decisions
- Articulates and documents strategy, deliverables, and timelines
- Identifies the correct parties for a document content decision
- Keeps discussions focused and on track
- Follows a discussion to its conclusion and synthesizes the message
- Establishes the requirements for department guidelines, templates, timelines, and SOPs to ensure compliance with applicable regulatory guidance and industry standards.
- Drive, lead, execute and deliver results for complex multi-functional projects
- Foresee potential problems before they arise and to solve problems that do arise while deciding the best course of action.
- Manages and mentors staff on document planning, processes, content and provides peer review as needed.
You have a PhD in a field of Science or Pharmacology and a minimum of 12+ years of pharmaceutical industry or related experience to include a minimum 8+ years of relevant Writing experience. Must also have at least 6+ years of people management experience.
- Strong capability to lead a team and develop talent by mentoring them through increased levels of responsibilities.
- Strong interpersonal skill to influence others in a positive and effective manner to build consensus
- In depth knowledge of drug development, regulatory writing, and associated regulations. Strong understanding of medical and scientific terminology across a range of therapeutic areas.
- Exceptional written communication skills along with the ability to independently interpret and summarize complex results
- Ability to develop and present varied and unique ideas and solutions
- Strong working knowledge of relevant software including Adobe, Veeva and Project. Skilled in use of MS Word. Have used 1 or more EDM systems.
Does this sound like you? Apply now to take your first steps toward living the Regeneron Way! We have an inclusive and diverse culture that provides amazing benefits including health and wellness programs, fitness centers and stock for employees at all levels!
Regeneron is an equal opportunity employer and all qualified applicants will receive consideration for employment without regard to race, color, religion or belief (or lack thereof), sex, nationality, national or ethnic origin, civil status, age, citizenship status, membership of the Traveler community, sexual orientation, disability, genetic information, familial status, marital or registered civil partnership status, pregnancy or maternity status, gender identity, gender reassignment, military or veteran status, or any other protected characteristic in accordance with applicable laws and regulations. We will ensure that individuals with disabilities are provided reasonable accommodations to participate in the job application process. Please contact us to discuss any accommodations you think you may need.