Principal Medical Writer

COMPANY DESCRIPTION:

Syner-G BioPharma Group and Sequoia Biotech Consulting recently merged in September 2024, uniting two industry leaders to create a new force in life sciences consulting. By combining our expertise in product development, regulatory strategy, quality and compliance and commercial manufacturing, we are positioned to deliver fully integrated solutions across the development continuum. 
 
We are helping to enhance human health. This merger strengthens our ability to accelerate groundbreaking therapies and help clients navigate the complex life sciences landscape with greater agility and confidence. Together, we form a leading life sciences consultancy dedicated to empowering organizations to overcome complex challenges and accelerate the speed to market, scale and quality of life-saving innovations.  

We work across a diverse range of clients and projects, supporting many organizations through the most critical phases of the drug discovery, approval, product development, technology transfer and commercial manufacturing process. We also equip our partners with the tools, knowledge and expertise to streamline operations, enhance quality and ensure compliance. 

Syner-G BioPharma Group was recently honored with BioSpace's prestigious "Best Places to Work" 2025 award, for the second consecutive year, along with many other award-winning programs to make a career here truly life-enhancing. These recognitions are a testament to our commitment to fostering a positive and engaging work environment for our employees, with a particular emphasis on culture, career growth and development opportunities, financial rewards, leadership and innovation. 

At Syner-G and Sequoia, we recognize that our team members are our most valuable asset. Join us in shaping the future, where your talents are valued, and your contributions make a meaningful impact. 

For more information, visit www.Sequoiabiotech.com/ or www.Synergbiopharma.com

POSITION OVERVIEW:

The Medical Writing Services Consultant II plays a pivotal role as a combined medical writer and project manager, leading complex regulatory and clinical writing initiatives within global product teams. This position involves mentoring junior writers, managing high-profile client relationships, and overseeing document creation and submission processes. With advanced expertise in regulatory requirements, therapeutic areas, and cross-functional collaboration, the MWS Principal ensures the delivery of high-quality, compliant documentation that supports global regulatory strategies.

WORK LOCATION:

This position is eligible for remote work based on company requirements, with no minimum in-office requirement.

JOB FUNCTIONS:

• Ability to combine medical writing and project management responsibilities within long-term product teams.
• Lead high-profile client projects, managing timelines, scope, and contracts while acting as the primary point of contact.
• Mentor junior writers, providing guidance on regulatory processes, document creation, and professional development.
• Author and oversee the preparation of clinical and regulatory submission documents, including clinical study reports, protocols, investigator brochures, safety reports, and other clinical regulatory submission/marketing application components.
• Coordinate with regulatory leads, SMEs, and cross-functional teams to align deliverables with global regulatory requirements.
• Track and report utilization rates to ensure efficient workload distribution and team productivity.
• Conduct senior reviews, ensuring documents meet quality standards and regulatory guidelines.
• Facilitate client meetings to discuss project goals, document progress, and resolve issues effectively.
• Synthesize complex clinical data into clear, concise documentation, adhering to ICH guidelines, FDA requirements, and industry-specific templates.
• Navigate therapeutic and regulatory requirements across diverse global markets, including the US, EU, Japan, and China.
• Troubleshoot project execution challenges, liaising with stakeholders to ensure timely and successful project delivery.

QUALIFICATIONS AND REQUIREMENTS:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the education, experience, skills, knowledge, and abilities required. Reasonable accommodation may be made to enable individuals with disabilities to perform essential duties.

Education:

• An advanced degree (e.g., M.S., PharmD, Ph.D., or M.D.) in life or health science is preferred.

Technical Skills:

• 4-5+ years industry experience.
• Strong background in clinical trials and lifecycle documentation.
• RAC certification preferred but not required.
• Exceptional leadership and mentoring skills to guide junior writers and foster team growth.
• Advanced knowledge of ICH guidelines, FDA requirements, and global regulatory standards.

Knowledge, Skills, and Abilities:

• Proficiency in MS Project, Word, Excel, Veeva Vault, and Please Review for document and project management.
• Resilience and negotiation skills for managing shifting priorities and achieving client goals.
• Strong organizational and communication skills for facilitating meetings, coordinating teams, and managing diverse projects.
• Commitment to staying updated on industry standards and regulatory changes to maintain compliance and best practices.
• Familiarity with document management systems and experience with SOP rollouts.
• Expertise in technical writing and data synthesis to produce high-quality deliverables.
• Flexibility in managing cross-time-zone collaborations and diverse project scopes.
• Ability to independently troubleshoot project-related issues and ensure smooth execution.

ESSENTIAL FUNCTIONS:

Physical Demands:

The physical demands described here are representative of the requirements that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

While performing the duties of this job, the employee is regularly required to use a computer keyboard and mouse; reach with hands and arms; talk and listen. The employee is frequently required to walk and sit. The employee is occasionally required to stand, stoop, or kneel. Specific vision abilities required by this position include close vision and the ability to adjust focus.

Work Environment:

The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job, including moderate noise level, an indoor temperate environment, and light levels that are bright and conducive to minimal eye strain, typical for an office environment.

TOTAL REWARDS:

We define total rewards as compensation, benefits, remote work/flexibility, development, recognition and our culture with programs that support each of our reward pillars. This includes a market competitive base salary and annual incentive plan, robust benefit offerings, and ongoing recognition and career development opportunities. Employees also enjoy our generous flexible paid time off program, company paid holidays, flexible working hours, and fully remote work options for most positions and the ability to work “almost anywhere”. However, if a physical work location is more for you, we have office locations in Greater Boston; Boulder, CO; and Chennai, India.

LEGAL STATEMENT:
 
Syner-G BioPharma Group and Sequoia Biotech Consulting are proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G BioPharma is an E-Verify employer. 

LEGAL STATEMENT:
 
Syner-G BioPharma Group and Sequoia Biotech Consulting are proud to be an Equal Employment Opportunity and Affirmative Action employers. All employment decisions, including the recruiting, hiring, placement, training availability, promotion, compensation, evaluation, disciplinary actions, and termination of employment (if necessary) are made without regard to the employee’s race, color, creed, religion, sex, pregnancy or childbirth, personal appearance, family responsibilities, sexual orientation or preference, gender identity, political affiliation, source of income, place of residence, national or ethnic origin, ancestry, age, marital status, military veteran status, unfavorable discharge from military service, physical or mental disability, or on any other basis prohibited by applicable law. Syner-G BioPharma is an E-Verify employer.