Senior Medical Writer, Promotional Review

Work Schedule Standard (Mon-Fri)

Environmental Conditions Office

Job Description The Senior Medical Writer - Promotional Review, provides high-quality medical and scientific writing from planning and coordination through delivery of final drafts to internal and external clients and demonstrates subject matter and therapeutic area expertise and may provide assistance to the program manager.

Additionally, as part of the Medical Affairs Consulting Team - the Senior Medical Writer may assist in medical affairs consulting services and the review of promotional medical materials against FDA-OPDP requirements. The role involves collaborating with internal and external clients, supporting and enabling effective and efficient communication that results in operational excellence.

What Youll Do:

Medical Information

• Serve as primary author who writes and provides input on routine medical information documents such as Standard Response Letters, Frequently Asked Questions (FAQs), and summarize data from clinical studies.
• Review routine documents prepared by junior team members. May provide training and mentorship for junior writers and program managers on document preparation, the use of software for document development, document types, regulatory requirements, and therapeutic area knowledge.
• Ensure compliance with quality processes and requirements for assigned documents. Provide input on and independently develops best practices, methods and techniques for achieving optimal results, including various client specific processes.
• May assist in program management activities. Identify and resolve out-of-scope activities. Duties could include developing timelines, budgets, forecasts and contract modifications.
• Represent the department at project launch meetings, review meetings, and project team meetings.

Promotional Review and Medical Affairs Consulting

• Reviews promotional and non-promotional materials for clinical and scientific accuracy against source documentation, reviews context and tone of language for compliance with applicable regulations and codes of practice (e.g., FDA, Health Canada, ABPI, EFPIA, IFPMA-AIFD) and assures appropriate level of language for intended audience (i.e., HCP, patient/consumer, other).
• Upon review and where consultative review comments are necessary, annotations are provided along with rationale and suggested language.
• Provide support for Medical Affairs and Field Force based materials, strategy planning, NCCN Submissions and other medical affairs-based activities.

Education & Experience Requirements:

• Bachelors degree in a scientific discipline or equivalent and relevant formal academic / vocational qualification; Advanced degree preferred
• Previous experience that provides the knowledge, skills, and abilities to perform the job (comparable to 5+ years)
• Equivalent of 3-years working experience in the independent review of promotional medical collateral as part of a Medical/Legal/Regulatory (MLR) Team or Promotional Review Committee
• Experience working in the pharmaceutical/CRO industry preferred
• Additional qualifications in medical writing (AMWA; EMWA; RAC) advantageous
• Strong background in Veeva PromoMats and related PRC CRM-based platforms

Knowledge, Skills, Abilities:

• Excellent data interpretation and medical writing skills, including grammatical, editorial, and proofreading skills
• Strong project management skills
• Excellent interpersonal skills including problem solving
• Strong negotiation skills
• Excellent oral and written communication skills with strong presentation skills
• Significant knowledge of global, regional, national and other relevant guidelines
• In-depth knowledge across therapeutic specialty areas
• Great judgment and decision-making skills
• Excellent computer skills and skilled with client templates; Good knowledge of document management systems and other relevant applications (e.g. Excel, Outlook)

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Job Title: Manager Operations

Job Description Join us as a Manager Operations - And lead our medical information operations team, oversee the development and dissemination of accurate medical and drug information, ensure compliance with regulatory standards, and support effective communication with healthcare professionals and stakeholders.

At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life - enabling our customers to make the world healthier, cleaner and safer. We provide our teams with the resources needed to achieve individual career goals while taking science a step beyond through research, development and delivery of life-changing therapies.

With clinical trials conducted in 100+ countries and ongoing development of novel frameworks for clinical research through our PPD clinical research portfolio, our work spans laboratory, digital and decentralized clinical trial services. Your determination to deliver quality and accuracy will improve health outcomes that people and communities depend on - now and in the future.

What You'll Do:

• May supervise program staff providing medical/clinical information, utilizing medical/clinical background to participate in, manage, and conduct quality review of medical/clinical work.
• Oversee and/or complete development of client reports and procedural documents.
• Maintain thorough program knowledge, with an emphasis on medical/clinical content (where applicable), troubleshoot program issues, monitor and ensure compliance with company policies and procedures including SOPs, protocols, and other regulations by conducting quality monitoring of staff work.
• Act as liaison between the client, program management and staff for operational issues such as workflow processes, available resources
• Oversee all aspects of program training including conducting training, developing curriculum, and documenting and maintaining training records and curriculum
• Act as a resource for front line staff for assistance with managing their scope of service.
• May function as the front-line healthcare professional agent to cover services including but not limited to answering medical/clinical inquiries (where applicable) and documenting contacts, adverse events and product complaints.
• Manage staff, which may include interviewing and selection, job description preparation, professional development, goal setting, performance management, coaching and mentoring, employee counseling, and separations.
• Approve courses of action on salary administration, hiring, corrective action, and terminations. Review and approve time records, expense reports, requests for leave, and overtime.

Education and Experience:

• Healthcare Degree (Bachelors Degree in Pharmacy or Nursing. Or Associates Degree in Nursing with 2 years nursing experience)
• Previous experience (comparable to 5+ years) in the healthcare or pharmaceutical industry with responsibilities involving counseling or providing medical information to include leadership experience (comparable to at least 1 year)
• Education may be substituted in lieu of some years of experience for advanced degrees such as Pharm.D, Ph.D. or MS
• In some cases a second language may be required
• Some programs may require a Pharm.D
• In most cases a license will be required
• In some cases an equivalency, consisting of a combination of appropriate education, training and/or directly related experience, will be considered sufficient for an individual to meet the requirements of the role

Knowledge, Skills, Abilities:

• Manages experienced professionals and / or subordinate management who exercise latitude and independence in their assignments. Often heads one or more sections or a small department.
• Responsible for training and development of subordinate staff, estimating personnel needs, assigning work, meeting completion dates, assisting subordinates with difficult inquiries or problems, interpreting and ensuring consistent application of organizational policies, and development and implementation of unit policies and procedures
• Recommends employees for employment, discipline, termination; initiates and communicates a variety of personnel actions (e.g. performance and salary reviews, promotions, time off requests, timesheet and expense report approvals)
• Strong leadership skills
• Strong attention to detail and organizational skills
• Effective verbal and written communication skills
• Excellent problem solving and analytical skills
• Demonstrated time management skills and multi-tasking skills
• Strong interpersonal and decision-making skills
• Ability to coach and train staff
• Excellent language skills must be demonstrated if the position requires languages other than English
• Ability to work in a team environment and/or independently as needed

Work Environment: Thermo Fisher values the health and wellbeing of our employees. We support and encourage individuals to create a healthy and balanced environment where they can thrive.

Below is listed the working environment/requirements for this role:

• Able to communicate, receive, and understand information and ideas with diverse groups of people in a comprehensible and reasonable manner.
• Able to work upright and stationary for typical working hours.
• Ability to use and learn standard office equipment and technology with proficiency.
• Able to perform successfully under pressure while prioritizing and handling multiple projects or activities.
• May require travel. (Recruiter will provide more details.)

Why Join Us? When you join Thermo Fisher Scientific, you become part of a global team that values passion, innovation, and a commitment to scientific excellence. You'll work in an environment where collaboration and development are part of the everyday experience-and where your contributions truly make a difference.

Apply today to help us deliver tomorrow's breakthroughs.

Compensation and Benefits The salary range estimated for this position based in Massachusetts is $130,000.00-$150,000.00.

This position may also be eligible to receive a variable annual bonus based on company, team, and/or individual performance results in accordance with company policy. We offer a comprehensive Total Rewards package that our U.S. colleagues and their families can count on, which includes:

• A choice of national medical and dental plans, and a national vision plan, including health incentive programs
• Employee assistance and family support programs, including commuter benefits and tuition reimbursement
• At least 120 hours paid time off (PTO), 10 paid holidays annually, paid parental leave (3 weeks for bonding and 8 weeks for caregiver leave), accident and life insurance, and short- and long-term disability in accordance with company policy
• Retirement and savings programs, such as our competitive 401(k) U.S. retirement savings plan
• Employees' Stock Purchase Plan (ESPP) offers eligible colleagues the opportunity to purchase company stock at a discount

For more information on our benefits, please visit: https://jobs.thermofisher.com/global/en/total-rewards