Associate Director/Director, Medical Writer Job at Lifelancer in Lexington

Job Description

Wave Life Sciences is a biotechnology company focused on unlocking the broad potential of RNA medicines to transform human health. Our RNA medicines platform, PRISM, combines multiple modalities, chemistry innovation and deep insights in human genetics to deliver scientific breakthroughs that treat both rare and prevalent disorders. Our toolkit of RNA-targeting modalities includes editing, splicing, RNA interference and antisense silencing, providing us with unmatched capabilities for designing and sustainably delivering candidates that optimally address disease biology. Our diversified pipeline includes clinical programs in Duchenne muscular dystrophy, Alpha-1 antitrypsin deficiency and Huntington’s disease, as well as a preclinical program in obesity. Driven by the calling to “Reimagine Possible”, we are leading the charge toward a world in which human potential is no longer hindered by the burden of disease.

Description

The Medical Writer role partners with Wave’s subject matter experts (SME) to prepare and deliver high-quality clinical and regulatory documents in support of clinical trials and regulatory submissions for multiple programs. This role will be responsible for authoring and/or developing clinical and nonclinical regulatory documents. This position can be remote or located in Lexington, MA.

Experience

• At a minimum, a B.A./B.S. degree in a scientific discipline; PhD/PharmD in life sciences is a plus
• At least 8-15 years of relevant industry experience as a medical/regulatory writer
• Experience working with/coordinating with external contractors/consultants.

Responsibilities

• In collaboration with the relevant SMEs, write regulatory documents including, but not limited to, Investigator’s Brochure, clinical study protocol and clinical study report; nonclinical and clinical Summary Documents
• Partner with the Regulatory Strategy Leads for the development of briefing packages for regulatory authority interactions in various regions; of global regulatory documents such as IND, CTA, NDA
• Manage timelines and communicate with team members to maintain awareness of expectations, milestones, and deliverables
• Proactively identify the need for, engage and oversee contract medical and/or regulatory writing resources
• Manage the document review, address comments and deliver scientifically accurate documents that meet regulatory requirements and industry best practices
• Create and maintain standard operating procedures or work instructions for preparation and maintenance of compliant medical and regulatory writing deliverables
• Attend team meetings on an agenda-driven basis and contribute to program goals, key messages, and timelines discussions
• Conduct and/or oversee quality control reviews of clinical and regulatory documents; implement the required changes
• Recommend improvements to the document preparation processes and templates to enhance efficiency and productivity
• Manage and/or oversee timely and compliant registration of clinical trials, information updates, and posting of results in trial registries such as clinicaltrials.gov

Key Skills

• Excellent writing and communication skills
• Strong interpersonal skills; a team player
• Flexibility to function well within a team environment and within condensed timelines
• Strong project management and organizational skills
• Understanding of drug development, clinical research, study design, biostatistics, pharmacokinetics, regulatory requirements, and medical terminology
• Ability to comply with company and/or industry style guides and templates
• Excellent attention to detail related to consistency, grammar, syntax, and scientific accuracy
• Technical expertise in Microsoft Word, Adobe Acrobat, and electronic document management systems

Wave Life Sciences provides equal employment opportunities (EEO) to all employees and applicants for employment without regard to race, color, religion, sex, national origin, age, disability or genetics. In addition to federal law requirements, Wave Life Sciences complies with applicable state and local laws governing nondiscrimination in employment in every location in which the company has facilities. This policy applies to all terms and conditions of employment, including recruiting, hiring, placement, promotion, termination, layoff, recall, transfer, leaves of absence, compensation and training.

Wave Life Sciences expressly prohibits any form of workplace harassment based on race, color, religion, gender, sexual orientation, gender identity or expression, national origin, age, genetic information, disability, or veteran status. Improper interference with the ability of Wave Life Sciences’ employees to perform their job duties may result in discipline up to and including discharge.

We value our relationships with professional recruitment firms. To protect the interests of all parties, and given the large volume of inquiries received from third-party placement agencies, we are not able to respond to all agency inquiries. We do not accept unsolicited resumes from any source other than directly from candidates for current or future positions. Submission of unsolicited resumes in advance of a signed agreement between our company and a placement agency does not create an implied obligation and, if an unsolicited candidate represented by a placement agency is hired, we are not obligated to pay a fee. Only approved recruitment firms will be allowed to provide services to Wave Life Sciences, USA.