Contract Technical Writer Remote Jobs in Raleigh, NC

Syneos Health is a leading fully-integrated life sciences services organization built to accelerate customer success. We partner with innovators at every point across the drug development and commercialization continuum, helping them navigate complexity, anticipate change and accelerate progress.
Our Clinical Solutions team members act with a drug development mindset, applying their years of experience and deep expertise to truly understand customer needs and represent those in the solutions we shape.
Whether you join us in a Functional Service Provider partnership or a Full-Service environment, you'll collaborate with passionate problem solvers, innovating as a team to help our customers achieve their goals. We are agile and driven to deliver - for one another, our customers, and, most importantly, for those in need.
Discover what your 25,000 future colleagues already know:
Why Syneos Health
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. Central to this is our purpose - Driven to Deliver - which captures the passion of our colleagues to show up each day and shape solutions that have the ability to dramatically impact someone's life.
We are continuously building the company we all want to work for and our customers want to work with. Why? Because we know that when we bring together smart colleagues from across the world, we can shape the future of healthcare, driving impact for customers and defining the pace of patient progress.

Job Responsibilities

Are you looking to grow your career in clinical research contracts and site start-up? We are seeking a Contract Manager I to join a high-performing Sponsor-Dedicated team supporting a leading global biopharmaceutical company. In this role, you will support the negotiation and management of clinical trial agreements, amendments, and study budgets while partnering with internal stakeholders and investigative sites to help advance clinical research.

This is an excellent opportunity for an early-career contracts professional who is detail-oriented, collaborative, and eager to develop expertise in clinical trial contracting and budgeting.

Required Qualifications

• Bachelor's degree in Business, Public Health, Life Sciences, or a related field (or equivalent experience).

• Up to two (2) years of experience in clinical research, site contracts and budgets, contract administration, or a related field.

• Basic understanding of:

  • Clinical Trial Agreements (CTAs)

  • Site budgets and budget negotiations

  • Contract lifecycle management processes

  • Clinical trial start-up activities

• Strong organizational skills with the ability to manage multiple priorities and deadlines.

• Excellent verbal and written communication skills.

• Strong attention to detail and problem-solving abilities.

• Ability to work collaboratively in a fast-paced, team-oriented environment.

• Proficiency in Microsoft Office Suite.

Preferred Qualifications

• Experience in a CRO, pharmaceutical, biotechnology, or clinical research environment.

• Exposure to clinical trial agreements, research budgets, or study start-up activities.

• Familiarity with clinical trial management systems (CTMS) or other contract tracking tools.

• Knowledge of ICH-GCP and clinical research processes.

• Manage the execution of Clinical Trial Agreement Amendments (CTA AMDs) and related contract documents using approved templates, fallback language, and Lead guidance.

• Manage execution of Confidentiality Disclosure Agreements (CDAs) using approved templates and Lead guidance.

• Support site budget amendment negotiations within established parameters and escalation guidelines.

• Track amendment negotiation activities and maintain accurate records in sponsor systems and internal tracking tools.

• Review/QC all deliverables for completeness, accuracy, and proper documentation.

• Attend internal and external project meetings and provide updates on assigned contract negotiations as required.

• Collaborate with cross-functional teams to support study start-up and site activation timelines.

• Build productive working relationships with investigative sites and internal stakeholders.

• Identify issues that may impact contract execution timelines and escalate as appropriate.

• Prepare contract and budget escalation packages when required.

• May support the finalization and execution of CTAs and initial budgets.

• Participate in process improvement initiatives, training, and developmental opportunities.

This role offers the opportunity to build a strong foundation in clinical trial contracting while working with an experienced Sponsor-Dedicated team. You will gain exposure to site contract negotiations, budget management, and clinical trial start-up activities while contributing to studies that help bring innovative therapies to patients.

At Syneos Health, we believe in providing an environment and culture in which Our People can thrive, develop and advance. We reward and recognize our people by providing valuable benefits and a quality-of-life balance. The benefits for this position may include a company car or car allowance, Health benefits to include Medical, Dental and Vision, Company match 401k, eligibility to participate in Employee Stock Purchase Plan, Eligibility to earn commissions/bonus based on company and individual performance, and flexible paid time off (PTO) and sick time. Because certain states and municipalities have regulated paid sick time requirements, eligibility for paid sick time may vary depending on where you work. Syneos complies with all applicable federal, state, and municipal paid sick time requirements.

Salary Range:

The base salary range represents the anticipated low and high of the Syneos Health range for this position. Actual salary will vary based on various factors such as the candidate's qualifications, skills, competencies, and proficiency for the role.

Get to know Syneos Health

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. Learn more about Syneos Health.

http://www.syneoshealth.com

Additional Information

Tasks, duties, and responsibilities as listed in this job description are not exhaustive. The Company, at its sole discretion and with no prior notice, may assign other tasks, duties, and job responsibilities. Equivalent experience, skills, and/or education will also be considered so qualifications of incumbents may differ from those listed in the Job Description. The Company, at its sole discretion, will determine what constitutes as equivalent to the qualifications described above. Further, nothing contained herein should be construed to create an employment contract. Occasionally, required skills/experiences for jobs are expressed in brief terms. Any language contained herein is intended to fully comply with all obligations imposed by the legislation of each country in which it operates, including the implementation of the EU Equality Directive, in relation to the recruitment and employment of its employees. The Company is committed to compliance with the Americans with Disabilities Act, including the provision of reasonable accommodations, when appropriate, to assist employees or applicants to perform the essential functions of the job.