Senior Manager – Medical Writing at Thermo Fisher Scientific Full Time

Responsibilities

• Effectively manages medical writing projects and regional operations ensuring high-quality and timely delivery of medical/scientific writing products to internal and external clients.
• Provides substantive advice on strategy, regulations, and industry best practices demonstrating subject matter and therapeutic area expertise.
• Manages the business development and pricing functions of projects for clients or alliance partners and contributes substantially to business development.
• Develops, mentors, and guides medical writing staff.
• Manages medical writers including management of workload, allocation of staff to projects, recruitment, development, training, performance, and personnel issues for managers and writers.
• Identifies needs and promotes development of new departmental processes and standards.
• Leads departmental teams for process improvement and participates in cross-functional process development.
• Provides support for writing routine or complex documents.
• Provides advice and guidance to writers on technical and regulatory aspects of document preparation.
• Serves as the first line of escalation for project risks.
• Develops and approves project budgets and advises direct reports on contract and budget issues for large complex projects.
• Participates in developing and reviewing proposal texts and budgets in collaboration with Proposal & Contracts Development.
• Assists with development of contract modifications and liaises with C&PD to follow through on all aspects of contract modification.
• Attends relevant FDA, industry, and scientific meetings and maintains relationships with industry contacts.

Requirements

• Bachelor’s degree in a science-related field required; Advanced degree (PharmD, PhD, Masters) preferred.
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 8+ years) or equivalent and relevant combination of education, training, & experience.
• 2+ years of management responsibility.
• Broad range of medical writing project experience and knowledge of global regulatory requirements for clinical trials, marketing authorization and late phase procedures.
• In-depth knowledge in a specialty area such as preclinical, therapeutic, regulatory, submissions.
• Excellent interpersonal skills including problem-solving, judgment, and decision-making skills.
• Ability to manage people including performance management, training, mentoring, directing and supervising work, and motivating employees.
• Strong project management skills, including the ability to plan and manage projects, create and modify project budgets, develop timelines, allocate resources, and forecast departmental workload.
• Strong communication, negotiation, and presentation skills needed to represent the department in various situations.
• In-depth knowledge of departmental processes; ability to identify emerging needs and propose/develop/ implement new or improved processes.
• Excellent medical writing skills, including grammatical, editorial, and proofreading skills, and the ability to interpret and present complex data.