Medical Writer – Woburn, MA
Summary of job description:
Reporting into the Chief Medical Officer, the Medical Writer will be responsible for assisting the CMO, clinical development and operations, regulatory affairs, medical affairs, biostatistics and translational research departments in writing and updating core documents and draft external presentations, as requested. The writer will maintain working knowledge of Replimune strategic plans and provide writing and editorial assistance on various documents, including clinical protocols, Investigator brochures, regulatory documents, clinical study reports, safety reports, biomarker-related documents, scientific abstracts and publications, healthcare provider and patient education materials and other written materials as requested. This position may also interact with external investigators and vendors in drafting and editing investigator-initiated clinical protocols, reports and publications. The position will also have access to pre-clinical data and assist in the drafting and editing of the biomarker-related and pre-clinical study reports, scientific abstracts and peer-reviewed manuscripts. The individual must have the ability to work independently and also as an effective and engaged team member in a fast-paced environment. Strong initiative and follow through are essential for this job. The ability to maintain confidentiality and to operate in the role with the highest of ethical standards and professionalism are required.
- Writing and editing clinical protocols and ensures appropriate formatting and accurate content in the document(s)
- Assists in writing and editing investigator brochures and ensures appropriate formatting and accurate content in the document(s).
- Develops and edits clinical study reports, as requested.
- Initiates and/or assists in writing and updating of clinical operations documents, including SAP, Pharmacy and Lab Manuals, etc.
- May assist in the development of technical reports and case report forms with the clinical operations team
- Develops and edits safety summaries, KRMs and other clinical documents, as requested.
- Contributes and assists in the writing and updating of clinical summary documents including DSURs and PSURs in support of regulatory submissions
- Helps draft and edit scientific abstracts and peer-reviewed manuscripts
- Helps Medical Affairs to develop healthcare provider and patient-related educational materials and E-learning modules
- Identify and builds relationships with investigators
- Contributes to drafting pre-clinical and biomarker-related study documents and manuscripts
- Works with communications group to draft and edit press releases and marketing reports
- Works with relevant teams to obtain accurate information and data for written materials
- Can work consistently in a matrix environment
- Responsible for maintaining working knowledge of Replimune scientific and clinical strategies to enable rapid and consistent written documentation
Educational and Experience/Skill requirements:
- Degree in science or medical related field
- Master’s degree preferred
- Ability to understand compliance with GCP and regulatory requirements
- Excellent written communication skills and knowledge of industry documentation
- Able to respond to queries and edits in a rapid manner
- Identify and builds relationships with study investigators, as appropriate
- Ability to work and communicate efficiently with internal and external partners
- Understanding of the fundamentals of clinical development and regulatory affairs (e.g. from working in a similar or an adjacent group in industry)
- Deep understanding of the fundamentals of protocol development and documentation formatting within the biotechnology industry
- Experience in biotechnology and/or pharmaceutic medical writing with a history of prior meaningful participation in regulatory submissions
- Proven team leadership capability
EEO & Employment Eligibility:
Replimune is committed to equal opportunity in the terms and conditions of employment for all employees and job applicants without regard to race, color, religion, sex, sexual orientation, age, gender identity or gender expression, national origin, ancestry origin, disability or veteran status. Replimune also complies with all applicable national, state and local laws governing nondiscrimination in employment as well as work authorization and employment eligibility verification requirements of the Immigration and Nationality Act and IRCA.
Replimune, Inc. does not accept agency resumes unless contacted directly by internal Replimune Talent Acquisition.
Please do not forward resumes to our careers site, employees or any other company location of Replimune. Replimune will not be responsible for any fees related to unsolicited resumes.